Trial Outcomes & Findings for A Study to Test Different Doses of BI 836880 Combined With Ezabenlimab in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours (NCT NCT03468426)
NCT ID: NCT03468426
Last Updated: 2025-11-10
Results Overview
Number of patients with dose limiting toxicity (DLT) within the first cycle of treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
252 participants
Primary outcome timeframe
The first treatment cycle, up to 21 days.
Results posted on
2025-11-10
Participant Flow
This was a non-randomised, uncontrolled, open-label, dose escalating trial of BI 836880 administered in combination with ezabenlimab intravenously every 3 weeks. The trial consisted of 2 parts: Part 1 (dose escalation of BI 836880 in combination with ezabenlimab) and Part 2 (expansion phase in 8 cohorts).
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Part 1 - BI 836880 360 mg
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort A, 2nd line NSCLC
Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort B, 3rd line NSCLC
Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after platinum-based chemotherapy and a check-point inhibitor (CPI) combination treatment as the most recent anticancer treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort C, SCLC
Patient with pathologically confirmed locally advanced or metastatic Small Cell Lung Cancer (SCLC) with documented intolerance to platinum-based chemotherapy or refractory to platinum-based chemotherapy. Patients who were platinumsensitive must also have received one additional prior line of platinum-based chemotherapy, if eligible, with or without combination with CPI as per applicable local treatment country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort D, glioblastoma
Patient with histologically confirmed recurrent glioblastoma with no more than two previous lines of chemotherapy. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma (HCC)
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
8
|
42
|
40
|
31
|
31
|
32
|
30
|
31
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
6
|
5
|
3
|
2
|
1
|
6
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
8
|
36
|
35
|
28
|
29
|
31
|
24
|
29
|
1
|
Reasons for withdrawal
| Measure |
Part 1 - BI 836880 360 mg
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort A, 2nd line NSCLC
Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort B, 3rd line NSCLC
Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after platinum-based chemotherapy and a check-point inhibitor (CPI) combination treatment as the most recent anticancer treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort C, SCLC
Patient with pathologically confirmed locally advanced or metastatic Small Cell Lung Cancer (SCLC) with documented intolerance to platinum-based chemotherapy or refractory to platinum-based chemotherapy. Patients who were platinumsensitive must also have received one additional prior line of platinum-based chemotherapy, if eligible, with or without combination with CPI as per applicable local treatment country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort D, glioblastoma
Patient with histologically confirmed recurrent glioblastoma with no more than two previous lines of chemotherapy. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma (HCC)
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive disease
|
3
|
0
|
4
|
20
|
23
|
15
|
24
|
27
|
13
|
13
|
0
|
|
Overall Study
Other adverse event or clinical progression
|
0
|
1
|
3
|
14
|
10
|
8
|
5
|
4
|
6
|
11
|
0
|
|
Overall Study
Refused to continue taking trial medication
|
0
|
0
|
0
|
2
|
0
|
3
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Other than listed
|
0
|
1
|
0
|
0
|
2
|
2
|
0
|
0
|
4
|
4
|
1
|
|
Overall Study
Dose Limiting Toxicity (DLT)
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
missing reason
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Test Different Doses of BI 836880 Combined With Ezabenlimab in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours
Baseline characteristics by cohort
| Measure |
Part 1 - BI 836880 360 mg
n=3 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=3 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=8 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort A, 2nd Line NSCLC
n=42 Participants
Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort B, 3rd Line NSCLC
n=40 Participants
Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after platinum-based chemotherapy and a check-point inhibitor (CPI) combination treatment as the most recent anticancer treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort C, SCLC
n=31 Participants
Patient with pathologically confirmed locally advanced or metastatic Small Cell Lung Cancer (SCLC) with documented intolerance to platinum-based chemotherapy or refractory to platinum-based chemotherapy. Patients who were platinumsensitive must also have received one additional prior line of platinum-based chemotherapy, if eligible, with or without combination with CPI as per applicable local treatment country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort D, Glioblastoma
n=31 Participants
Patient with histologically confirmed recurrent glioblastoma with no more than two previous lines of chemotherapy. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
n=32 Participants
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd Line Hepatocellular Carcinoma
n=30 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st Line Hepatocellular Carcinoma (HCC)
n=31 Participants
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd Line HCC - Atezolizumab in Combination With Bevacizumab Failures
n=1 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.3 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
60.3 Years
STANDARD_DEVIATION 2.1 • n=20 Participants
|
58.3 Years
STANDARD_DEVIATION 12.1 • n=40 Participants
|
64.3 Years
STANDARD_DEVIATION 9.1 • n=28 Participants
|
59.2 Years
STANDARD_DEVIATION 10.1 • n=46 Participants
|
63.1 Years
STANDARD_DEVIATION 11.7 • n=34 Participants
|
56.7 Years
STANDARD_DEVIATION 9.5 • n=22 Participants
|
59.9 Years
STANDARD_DEVIATION 14.7 • n=226 Participants
|
64.4 Years
STANDARD_DEVIATION 8.8 • n=3 Participants
|
63.6 Years
STANDARD_DEVIATION 9.4 • n=6 Participants
|
55 Years
STANDARD_DEVIATION na • n=6 Participants
|
61.4 Years
STANDARD_DEVIATION 10.8 • n=6 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
15 Participants
n=28 Participants
|
18 Participants
n=46 Participants
|
10 Participants
n=34 Participants
|
10 Participants
n=22 Participants
|
10 Participants
n=226 Participants
|
4 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
80 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
27 Participants
n=28 Participants
|
22 Participants
n=46 Participants
|
21 Participants
n=34 Participants
|
21 Participants
n=22 Participants
|
22 Participants
n=226 Participants
|
26 Participants
n=3 Participants
|
24 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
172 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
1 Participants
n=34 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=226 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
29 Participants
n=28 Participants
|
17 Participants
n=46 Participants
|
25 Participants
n=34 Participants
|
26 Participants
n=22 Participants
|
15 Participants
n=226 Participants
|
20 Participants
n=3 Participants
|
31 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
172 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
13 Participants
n=28 Participants
|
23 Participants
n=46 Participants
|
5 Participants
n=34 Participants
|
4 Participants
n=22 Participants
|
16 Participants
n=226 Participants
|
10 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
77 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=226 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
10 Participants
n=28 Participants
|
3 Participants
n=46 Participants
|
4 Participants
n=34 Participants
|
6 Participants
n=22 Participants
|
4 Participants
n=226 Participants
|
8 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
39 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=226 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=226 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
19 Participants
n=28 Participants
|
14 Participants
n=46 Participants
|
24 Participants
n=34 Participants
|
20 Participants
n=22 Participants
|
12 Participants
n=226 Participants
|
12 Participants
n=3 Participants
|
25 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
135 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=226 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
13 Participants
n=28 Participants
|
23 Participants
n=46 Participants
|
3 Participants
n=34 Participants
|
4 Participants
n=22 Participants
|
16 Participants
n=226 Participants
|
10 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
75 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: The first treatment cycle, up to 21 days.Population: Maximum tolerated dose (MTD) set: This patient set includes all patients enrolled in dose escalation and confirmation of MTD cohort of the trial (Part 1) who were documented to have received at least one dose of ezabenlimab or BI 836880 and were evaluable for the MTD determination.
Number of patients with dose limiting toxicity (DLT) within the first cycle of treatment.
Outcome measures
| Measure |
Part 1 - total
n=14 Participants
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=3 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=3 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=8 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1 - Number of Patients With Dose Limiting Toxicity (DLT) Within the First Cycle of Treatment
|
1 Participants
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 778 days.Population: All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
Objective Response (OR) defined as best overall response (Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)) of complete response (CR) or partial response (PR) from first treatment infusion until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent. In case of recurrent glioblastoma (GBM), assessment will be based on RANO (Response Assessment in Neuro-Oncology) criteria.
Outcome measures
| Measure |
Part 1 - total
n=31 Participants
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
n=238 Participants
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=42 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=40 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=31 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
n=32 Participants
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
n=30 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
n=31 Participants
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
n=1 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2 - Objective Response (OR)
|
7 Participants
|
45 Participants
|
7 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
12 Participants
|
8 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1263 days.Population: All patients enrolled in part 1 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
The number of patients with any adverse events (AEs).
Outcome measures
| Measure |
Part 1 - total
n=14 Participants
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=3 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=3 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=8 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1 - Adverse Events (AEs)
|
14 Participants
|
—
|
3 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1263 days.Population: All patients enrolled in part 1 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
The number of patients with any drug related adverse events (AEs).
Outcome measures
| Measure |
Part 1 - total
n=14 Participants
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=3 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=3 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=8 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1 - Drug Related AEs
|
12 Participants
|
—
|
3 Participants
|
2 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1263 days.Population: All patients enrolled in part 1 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
The number of patients with any drug related adverse events (AEs) leading to dose reduction or discontinuation.
Outcome measures
| Measure |
Part 1 - total
n=14 Participants
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=3 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=3 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=8 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1 - Drug Related AEs Leading to Dose Reduction or Discontinuation
Subjects with AEs leading to dose reduction of trial drug
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 1 - Drug Related AEs Leading to Dose Reduction or Discontinuation
Subjects with AEs leading to discontinuation of trial drug
|
4 Participants
|
—
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 778 days.Population: All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
The number of patients with any adverse events (AEs).
Outcome measures
| Measure |
Part 1 - total
n=31 Participants
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
n=238 Participants
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=42 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=40 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=31 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
n=32 Participants
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
n=30 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
n=31 Participants
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
n=1 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2 - Adverse Events (AEs)
|
30 Participants
|
223 Participants
|
39 Participants
|
39 Participants
|
27 Participants
|
31 Participants
|
28 Participants
|
28 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 778 days.Population: All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
The number of patients with any drug related adverse events (AEs).
Outcome measures
| Measure |
Part 1 - total
n=31 Participants
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
n=238 Participants
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=42 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=40 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=31 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
n=32 Participants
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
n=30 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
n=31 Participants
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
n=1 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2 - Drug Related AEs
|
24 Participants
|
160 Participants
|
27 Participants
|
27 Participants
|
16 Participants
|
18 Participants
|
27 Participants
|
20 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 778 days.Population: All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
The number of patients with any drug related adverse events (AEs) leading to dose reduction or discontinuation.
Outcome measures
| Measure |
Part 1 - total
n=31 Participants
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
n=238 Participants
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=42 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=40 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=31 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
n=32 Participants
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
n=30 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
n=31 Participants
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
n=1 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2 - Drug Related AEs Leading to Dose Reduction or Discontinuation
Subjects with AEs leading to dose reduction of trial drug
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Part 2 - Drug Related AEs Leading to Dose Reduction or Discontinuation
Subjects with AEs leading to discontinuation of trial drug
|
2 Participants
|
38 Participants
|
13 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 778 days.Population: All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
Disease control (DC), defined as best overall response of CR, PR, or stable disease (SD) (Response Assessment in Neuro-Oncology (RANO for GBM \& RECIST1.1 for all other cohorts).
Outcome measures
| Measure |
Part 1 - total
n=31 Participants
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
n=238 Participants
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=42 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=40 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=31 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
n=32 Participants
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
n=30 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
n=31 Participants
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
n=1 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2 - Disease Control (DC)
|
25 Participants
|
164 Participants
|
34 Participants
|
25 Participants
|
12 Participants
|
18 Participants
|
24 Participants
|
25 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 84.4 weeks.Population: All patients with an objective response enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
Duration of objective response (DoR), defined as the time from first documented CR or PR (RANO for GBM \& RECIST1.1 for all other cohorts) until the earliest of disease progression or death among patients with OR.
Outcome measures
| Measure |
Part 1 - total
n=7 Participants
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
n=45 Participants
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=7 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=3 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=6 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
n=2 Participants
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
n=12 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
n=8 Participants
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2 - Duration of Objective Response (DoR)
|
18.1 weeks
Interval 10.7 to 78.3
|
48.3 weeks
Interval 6.3 to 84.4
|
23.4 weeks
Interval 7.6 to 65.3
|
54.0 weeks
Interval 48.4 to 58.0
|
30.0 weeks
Interval 12.0 to 73.1
|
43.3 weeks
Interval 19.3 to 67.3
|
53.8 weeks
Interval 6.3 to 84.4
|
48.9 weeks
Interval 12.3 to 78.1
|
—
|
SECONDARY outcome
Timeframe: Up to 778 days.Population: All patients enrolled in part 2 of the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
Progression-free survival (PFS) (RANO for GBM \& RECIST1.1 for all other cohorts), defined as the time from first treatment infusion until disease progression or death from any cause, whichever occurs earlier. Tumour shrinkage (in millimeters), defined as the difference between the minimum post-baseline sum of diameters of target lesions (longest for non-nodal lesions, short axis for nodal lesions) and the baseline sum of diameters of the same set of target lesions in case of RECIST. In GBM, using RANO criteria, tumor shrinkage will be calculated based on the difference between the post-baseline and baseline measurements of the sum of product of the largest bi-dimensional measurements for all target lesions.
Outcome measures
| Measure |
Part 1 - total
n=31 Participants
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
n=238 Participants
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=42 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=40 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=31 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
n=32 Participants
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
n=30 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
n=31 Participants
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
n=1 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2 - Progression-free Survival (PFS)
|
16.43 weeks
Interval 11.43 to 59.86
|
28.00 weeks
Interval 8.86 to 72.0
|
43.14 weeks
Interval 15.14 to 72.29
|
20.43 weeks
Interval 7.29 to
Not enough events reached to calculate the upper limit.
|
6.29 weeks
Interval 5.29 to 44.71
|
27.86 weeks
Interval 6.64 to 47.71
|
78.14 weeks
Interval 11.86 to
Not enough events reached to calculate the upper limit.
|
37.00 weeks
Interval 9.14 to 67.14
|
17.86 weeks
Interval 17.86 to 17.86
|
SECONDARY outcome
Timeframe: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.Population: PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.
Part 1 - Maximum measured concentration of BI 836880 in plasma (Cmax) after the first infusion cycle.
Outcome measures
| Measure |
Part 1 - total
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=1 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=3 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the First Infusion Cycle
|
—
|
—
|
—
|
NA microgram/milliliter
Geometric Coefficient of Variation na
not disclosed due to data protection.
|
175 microgram/milliliter
Geometric Coefficient of Variation 21.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle.Population: PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.
Part 1 - Maximum measured concentration of BI 836880 in plasma (Cmax) after the fourth infusion cycle.
Outcome measures
| Measure |
Part 1 - total
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=1 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=4 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the Fourth Infusion Cycle
|
—
|
—
|
—
|
NA microgram/milliliter
Geometric Coefficient of Variation na
not disclosed due to data protection.
|
273 microgram/milliliter
Geometric Coefficient of Variation 20.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.Population: PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.
Part 1 - Time from dosing to maximum serum concentration of BI 836880 (Tmax) after the first infusion cycle.
Outcome measures
| Measure |
Part 1 - total
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=1 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=3 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1 - Time From Dosing to Maximum Serum Concentration of BI 836880 (Tmax) After the First Infusion Cycle
|
—
|
—
|
—
|
NA hours
Geometric Coefficient of Variation na
not disclosed due to data protection.
|
1.84 hours
Geometric Coefficient of Variation 134
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle.Population: PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.
Part 1 - Time from dosing to maximum serum concentration of BI 836880 (Tmax) after the fourth infusion cycle.
Outcome measures
| Measure |
Part 1 - total
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=1 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=4 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1 - Time From Dosing to Maximum Serum Concentration of BI 836880 (Tmax) After the Fourth Infusion Cycle
|
—
|
—
|
—
|
NA hours
Geometric Coefficient of Variation na
not disclosed due to data protection.
|
3.29 hours
Geometric Coefficient of Variation 91.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.Population: PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.
Part 1 - Area under the concentration-time curve of BI 836880 in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the first infusion cycle.
Outcome measures
| Measure |
Part 1 - total
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=2 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=4 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1 - Area Under the Concentration-time Curve of BI 836880 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle
|
—
|
—
|
—
|
19200 hours*microgram/milliliter
Geometric Coefficient of Variation 28.5
|
35100 hours*microgram/milliliter
Geometric Coefficient of Variation 20.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle.Population: PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.
Part 1 - Area under the concentration-time curve of BI 836880 in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the fourth infusion cycle.
Outcome measures
| Measure |
Part 1 - total
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=1 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=4 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1 - Area Under the Concentration-time Curve of BI 836880 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the Fourth Infusion Cycle
|
—
|
—
|
—
|
NA hours*microgram/milliliter
Geometric Coefficient of Variation na
not disclosed due to data protection.
|
59700 hours*microgram/milliliter
Geometric Coefficient of Variation 14.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.Population: PK analysis set (PKS) part 2: This patient set included all patients in part 2 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.
Part 2 - Maximum measured concentration of BI 836880 in plasma (Cmax) after the first infusion cycle.
Outcome measures
| Measure |
Part 1 - total
n=30 Participants
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=38 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=38 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=29 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
n=25 Participants
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
n=30 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
n=25 Participants
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
n=1 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2 - Maximum Measured Concentration of BI 836880 in Plasma (Cmax) After the First Infusion Cycle
|
253 microgram/milliliter
Geometric Coefficient of Variation 23.4
|
—
|
251 microgram/milliliter
Geometric Coefficient of Variation 25.5
|
239 microgram/milliliter
Geometric Coefficient of Variation 30.5
|
275 microgram/milliliter
Geometric Coefficient of Variation 39.8
|
240 microgram/milliliter
Geometric Coefficient of Variation 27.2
|
214 microgram/milliliter
Geometric Coefficient of Variation 20.5
|
206 microgram/milliliter
Geometric Coefficient of Variation 31.7
|
NA microgram/milliliter
Geometric Coefficient of Variation na
not disclosed due to data protection.
|
SECONDARY outcome
Timeframe: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.Population: PK analysis set (PKS) part 2: This patient set included all patients in part 2 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.
Part 2 - Time from dosing to maximum serum concentration of BI 836880 (Tmax) after the first infusion cycle.
Outcome measures
| Measure |
Part 1 - total
n=30 Participants
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=38 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=38 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=29 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
n=25 Participants
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
n=30 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
n=25 Participants
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
n=1 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2 - Time From Dosing to Maximum Serum Concentration of BI 836880 (Tmax) After the First Infusion Cycle
|
2.18 hours
Geometric Coefficient of Variation 73.9
|
—
|
2.75 hours
Geometric Coefficient of Variation 72.0
|
2.61 hours
Geometric Coefficient of Variation 91.6
|
2.25 hours
Geometric Coefficient of Variation 76.9
|
2.47 hours
Geometric Coefficient of Variation 76.7
|
3.08 hours
Geometric Coefficient of Variation 109
|
2.54 hours
Geometric Coefficient of Variation 113
|
NA hours
Geometric Coefficient of Variation na
not disclosed due to data protection.
|
SECONDARY outcome
Timeframe: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.Population: PK analysis set (PKS) part 2: This patient set included all patients in part 2 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.
Part 2 - Area under the concentration-time curve of BI 836880 in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the first infusion cycle.
Outcome measures
| Measure |
Part 1 - total
n=28 Participants
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=35 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=32 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=18 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
n=28 Participants
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
n=24 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
n=24 Participants
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
n=1 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2 - Area Under the Concentration-time Curve of BI 836880 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle
|
44900 hours*microgram/milliliter
Geometric Coefficient of Variation 22.4
|
—
|
44000 hours*microgram/milliliter
Geometric Coefficient of Variation 28.2
|
41300 hours*microgram/milliliter
Geometric Coefficient of Variation 31.1
|
42000 hours*microgram/milliliter
Geometric Coefficient of Variation 11.1
|
38000 hours*microgram/milliliter
Geometric Coefficient of Variation 23.8
|
39400 hours*microgram/milliliter
Geometric Coefficient of Variation 21.4
|
36600 hours*microgram/milliliter
Geometric Coefficient of Variation 25.2
|
NA hours*microgram/milliliter
Geometric Coefficient of Variation na
not disclosed due to data protection.
|
SECONDARY outcome
Timeframe: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.Population: PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.
Part 1 - Maximum measured concentration of ezabenlimab in plasma (Cmax) after the first infusion cycle.
Outcome measures
| Measure |
Part 1 - total
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=3 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=2 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=7 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1 - Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) After the First Infusion Cycle
|
—
|
—
|
80.7 microgram/milliliter
Geometric Coefficient of Variation 24.8
|
144 microgram/milliliter
Geometric Coefficient of Variation 78.9
|
75.8 microgram/milliliter
Geometric Coefficient of Variation 25.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle.Population: PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.
Part 1 - Maximum measured concentration of ezabenlimab in plasma (Cmax) after the fourth infusion cycle.
Outcome measures
| Measure |
Part 1 - total
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=1 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=2 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=6 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1 - Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) After the Fourth Infusion Cycle
|
—
|
—
|
NA microgram/milliliter
Geometric Coefficient of Variation na
not disclosed due to data protection.
|
131 microgram/milliliter
Geometric Coefficient of Variation 16.2
|
106 microgram/milliliter
Geometric Coefficient of Variation 20.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.Population: PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.
Part 1 - Time from dosing to maximum serum concentration of ezabenlimab (Tmax) after the first infusion cycle.
Outcome measures
| Measure |
Part 1 - total
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=3 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=2 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=7 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1 - Time From Dosing to Maximum Serum Concentration of Ezabenlimab (Tmax) After the First Infusion Cycle
|
—
|
—
|
1.83 hours
Geometric Coefficient of Variation 137
|
1.06 hours
Geometric Coefficient of Variation 7.84
|
2.79 hours
Geometric Coefficient of Variation 101
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle.Population: PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.
Part 1 - Time from dosing to maximum serum concentration of ezabenlimab (Tmax) after the fourth infusion cycle.
Outcome measures
| Measure |
Part 1 - total
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=1 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=2 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=6 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1 - Time From Dosing to Maximum Serum Concentration of Ezabenlimab (Tmax) After the Fourth Infusion Cycle
|
—
|
—
|
NA hours
Geometric Coefficient of Variation na
not disclosed due to data protection.
|
1.55 hours
Geometric Coefficient of Variation 65.5
|
2.32 hours
Geometric Coefficient of Variation 55.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.Population: PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.
Part 1 - Area under the concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the first infusion cycle.
Outcome measures
| Measure |
Part 1 - total
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=3 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=2 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=7 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1 - Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle
|
—
|
—
|
15100 hours*microgram/milliliter
Geometric Coefficient of Variation 42.0
|
15800 hours*microgram/milliliter
Geometric Coefficient of Variation 8.13
|
14900 hours*microgram/milliliter
Geometric Coefficient of Variation 27.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the fourth cycle.Population: PK analysis set (PKS) part 1: This patient set included all patients in part 1 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.
Part 1 - Area under the concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the fourth infusion cycle.
Outcome measures
| Measure |
Part 1 - total
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=1 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=2 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=5 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1 - Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the Fourth Infusion Cycle
|
—
|
—
|
NA hours*microgram/milliliter
Geometric Coefficient of Variation na
not disclosed due to data protection.
|
34000 hours*microgram/milliliter
Geometric Coefficient of Variation 17.8
|
25200 hours*microgram/milliliter
Geometric Coefficient of Variation 32.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.Population: PK analysis set (PKS) part 2: This patient set included all patients in part 2 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.
Part 2 - Maximum measured concentration of ezabenlimab in plasma (Cmax) after the first infusion cycle.
Outcome measures
| Measure |
Part 1 - total
n=29 Participants
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=41 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=38 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=28 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
n=27 Participants
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
n=28 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
n=29 Participants
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
n=1 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2 - Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) After the First Infusion Cycle
|
87.7 microgram/milliliter
Geometric Coefficient of Variation 22.3
|
—
|
85.7 microgram/milliliter
Geometric Coefficient of Variation 26.3
|
80.5 microgram/milliliter
Geometric Coefficient of Variation 22.0
|
89.3 microgram/milliliter
Geometric Coefficient of Variation 27.8
|
76.6 microgram/milliliter
Geometric Coefficient of Variation 18.2
|
74.6 microgram/milliliter
Geometric Coefficient of Variation 20.1
|
71.3 microgram/milliliter
Geometric Coefficient of Variation 28.3
|
NA microgram/milliliter
Geometric Coefficient of Variation na
not disclosed due to data protection.
|
SECONDARY outcome
Timeframe: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.Population: PK analysis set (PKS) part 2: This patient set included all patients in part 2 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.
Part 2 - Time from dosing to maximum serum concentration of ezabenlimab (Tmax) after the first infusion cycle.
Outcome measures
| Measure |
Part 1 - total
n=29 Participants
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=41 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=38 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=28 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
n=27 Participants
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
n=28 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
n=29 Participants
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
n=1 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2 - Time From Dosing to Maximum Serum Concentration of Ezabenlimab (Tmax) After the First Infusion Cycle
|
2.35 hours
Geometric Coefficient of Variation 84.8
|
—
|
2.93 hours
Geometric Coefficient of Variation 129
|
2.90 hours
Geometric Coefficient of Variation 68.2
|
2.26 hours
Geometric Coefficient of Variation 77.8
|
3.03 hours
Geometric Coefficient of Variation 65.9
|
2.38 hours
Geometric Coefficient of Variation 63.8
|
2.75 hours
Geometric Coefficient of Variation 110
|
NA hours
Geometric Coefficient of Variation na
not disclosed due to data protection.
|
SECONDARY outcome
Timeframe: 5 minutes before infusion and 1, 2.25, 6, 24, 168, 336 and 504 hours following the end of infusion in the first cycle.Population: PK analysis set (PKS) part 2: This patient set included all patients in part 2 of the trial in the treated set who provide at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviation. Only subjects with available data were included, subjects were excluded due to various reasons, e.g., sample time deviations, deviations in dose or dosing time or too high predose concentrations.
Part 2 - Area under the concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours (AUC0-504h) after the first infusion cycle.
Outcome measures
| Measure |
Part 1 - total
n=30 Participants
All patients in part 1 Patients received BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - total
All patients in part 2. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 360 mg
n=36 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=34 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=17 Participants
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
n=31 Participants
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
n=25 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
n=26 Participants
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
n=1 Participants
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab. Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2 - Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504h) After the First Infusion Cycle
|
19300 hours*microgram/milliliter
Geometric Coefficient of Variation 22.1
|
—
|
17600 hours*microgram/milliliter
Geometric Coefficient of Variation 29.7
|
15200 hours*microgram/milliliter
Geometric Coefficient of Variation 35.2
|
17700 hours*microgram/milliliter
Geometric Coefficient of Variation 16.9
|
14500 hours*microgram/milliliter
Geometric Coefficient of Variation 25.5
|
14900 hours*microgram/milliliter
Geometric Coefficient of Variation 23.1
|
14200 hours*microgram/milliliter
Geometric Coefficient of Variation 31.5
|
NA hours*microgram/milliliter
Geometric Coefficient of Variation na
not disclosed due to data protection.
|
Adverse Events
Part 1 - BI 836880 360 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 - BI 836880 500 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 1 - BI 836880 720 mg
Serious events: 6 serious events
Other events: 8 other events
Deaths: 1 deaths
Part 2 - Cohort A, 2nd line NSCLC
Serious events: 24 serious events
Other events: 36 other events
Deaths: 4 deaths
Part 2 - Cohort B, 3rd line NSCLC
Serious events: 21 serious events
Other events: 35 other events
Deaths: 2 deaths
Part 2 - Cohort C, SCLC
Serious events: 14 serious events
Other events: 23 other events
Deaths: 5 deaths
Part 2 - Cohort D, glioblastoma
Serious events: 10 serious events
Other events: 28 other events
Deaths: 1 deaths
Part 2 - Cohort E, Melanoma
Serious events: 11 serious events
Other events: 30 other events
Deaths: 2 deaths
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
Serious events: 16 serious events
Other events: 28 other events
Deaths: 4 deaths
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
Serious events: 17 serious events
Other events: 27 other events
Deaths: 5 deaths
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 - BI 836880 360 mg
n=3 participants at risk
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=3 participants at risk
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=8 participants at risk
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort A, 2nd line NSCLC
n=42 participants at risk
Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice.
Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort B, 3rd line NSCLC
n=40 participants at risk
Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after platinum-based chemotherapy and a check-point inhibitor (CPI) combination treatment as the most recent anticancer treatment.
Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort C, SCLC
n=31 participants at risk
Patient with pathologically confirmed locally advanced or metastatic Small Cell Lung Cancer (SCLC) with documented intolerance to platinum-based chemotherapy or refractory to platinum-based chemotherapy. Patients who were platinumsensitive must also have received one additional prior line of platinum-based chemotherapy, if eligible, with or without combination with CPI as per applicable local treatment country guidelines.
Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort D, glioblastoma
n=31 participants at risk
Patient with histologically confirmed recurrent glioblastoma with no more than two previous lines of chemotherapy.
Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
n=32 participants at risk
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines.
Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
n=30 participants at risk
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment.
Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
n=31 participants at risk
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved.
Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
n=1 participants at risk
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab.
Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Chills
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Fatigue
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Death
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Chest pain
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Stoma site cellulitis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
5.0%
2/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Product issues
Device breakage
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Gastroduodenal haemorrhage
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
5.0%
2/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Asthenia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Disease progression
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Hyperthermia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Ill-defined disorder
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Pain
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Perforated ulcer
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory distress
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Coma scale abnormal
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Paraneoplastic myelopathy
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Product issues
Thrombosis in device
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
5.0%
2/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.2%
2/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
Other adverse events
| Measure |
Part 1 - BI 836880 360 mg
n=3 participants at risk
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 360 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 500 mg
n=3 participants at risk
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 500 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 1 - BI 836880 720 mg
n=8 participants at risk
Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed during or after first line platinum-based chemotherapy, received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort A, 2nd line NSCLC
n=42 participants at risk
Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after check-point inhibitor monotherapy treatment. Patient must also have received treatment with a platinum-based chemotherapy regimen and have progressed or be intolerant, or ineligible, as per applicable local practice.
Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort B, 3rd line NSCLC
n=40 participants at risk
Patient with pathologically confirmed locally advanced or metastatic non-squamous NSCLC who progressed during or after platinum-based chemotherapy and a check-point inhibitor (CPI) combination treatment as the most recent anticancer treatment.
Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort C, SCLC
n=31 participants at risk
Patient with pathologically confirmed locally advanced or metastatic Small Cell Lung Cancer (SCLC) with documented intolerance to platinum-based chemotherapy or refractory to platinum-based chemotherapy. Patients who were platinumsensitive must also have received one additional prior line of platinum-based chemotherapy, if eligible, with or without combination with CPI as per applicable local treatment country guidelines.
Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort D, glioblastoma
n=31 participants at risk
Patient with histologically confirmed recurrent glioblastoma with no more than two previous lines of chemotherapy.
Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort E, Melanoma
n=32 participants at risk
Patient with histologically confirmed, unresectable, Stage IV metastatic melanoma who progressed during or after CPI based regimen. Patients with a BRAF mutation must have received targeted treatment, or were not eligible, with a BRAF and MEK inhibitor as per applicable local country guidelines.
Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort F, 2nd line Hepatocellular Carcinoma
n=30 participants at risk
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line sorafenib or lenvatinib treatment.
Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort G, 1st line Hepatocellular Carcinoma
n=31 participants at risk
Patient with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. This will be implemented only in countries where this cohort is approved.
Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
Part 2 - Cohort H, 2nd line HCC - atezolizumab in combination with bevacizumab failures
n=1 participants at risk
Patient with locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC) who were intolerant or progressed during 1st line treatment with atezolizumab in combination with bevacizumab.
Patients received 720 milligram (mg) BI 836880 and 240 mg Ezabenlimab (BI 754091) as an intravenous infusion on day 1 of each 3-week cycle until progression, unacceptable toxicity, or up to a maximum of 53 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.5%
4/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.2%
2/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
16.7%
5/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
19.4%
6/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
5/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Fatigue
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
37.5%
3/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
15.0%
6/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.4%
3/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
13.3%
4/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
16.1%
5/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
25.0%
2/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
14.3%
6/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
5/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
4/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
13.3%
4/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
100.0%
1/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
11.9%
5/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
5/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.4%
3/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
37.5%
3/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
26.2%
11/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
4/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
28.1%
9/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
30.0%
9/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
16.1%
5/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
100.0%
1/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Asthenia
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
37.5%
3/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
28.6%
12/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
35.0%
14/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
25.8%
8/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
29.0%
9/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
31.2%
10/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
23.3%
7/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Chest pain
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
66.7%
2/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
4/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Inflammation
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
11.9%
5/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
4/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.4%
3/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
30.0%
9/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.5%
3/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
13.3%
4/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
16.1%
5/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.5%
4/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
20.0%
8/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.2%
2/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
16.7%
5/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.5%
4/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
15.0%
6/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.2%
2/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
3/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
11.9%
5/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
22.5%
9/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
25.0%
2/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
21.4%
9/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
20.0%
8/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
28.1%
9/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
16.7%
5/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
100.0%
1/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
4/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.2%
2/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
3/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
100.0%
1/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
25.0%
2/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
11.9%
5/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
5.0%
2/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
15.6%
5/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
26.7%
8/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.5%
3/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
4/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
3/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
25.0%
2/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.5%
3/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
3/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
66.7%
2/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.5%
4/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
4/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
4/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
16.7%
5/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
16.7%
7/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
5.0%
2/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
16.1%
5/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.2%
2/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
43.3%
13/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
2/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
66.7%
2/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
25.0%
2/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
21.4%
9/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
17.5%
7/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
16.1%
5/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
4/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
20.0%
6/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
14.3%
6/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
20.0%
8/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
22.6%
7/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
4/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
66.7%
2/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
11.9%
5/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
5.0%
2/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.4%
3/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
23.3%
7/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
100.0%
1/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
5/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
4/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
66.7%
2/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
62.5%
5/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
23.8%
10/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
22.5%
9/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
25.8%
8/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
4/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
43.3%
13/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
100.0%
1/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Blood and lymphatic system disorders
Hyperleukocytosis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
5.0%
2/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
25.0%
2/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.5%
3/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
4/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
5.0%
2/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
3/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
19.4%
6/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
25.0%
2/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.2%
2/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
5.0%
2/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
5.0%
2/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
3/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Eye disorders
Eye discharge
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
5/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
3/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
100.0%
1/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
3/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
25.8%
8/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.4%
3/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
66.7%
2/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
50.0%
4/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
14.3%
6/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
20.0%
8/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
15.6%
5/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
100.0%
1/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
66.7%
2/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
50.0%
4/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
14.3%
6/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.5%
3/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.4%
3/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Face oedema
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Hyperthermia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Oedema
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Pain
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.5%
3/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.4%
3/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
25.0%
2/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.2%
2/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.5%
4/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
5.0%
2/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.2%
2/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.2%
2/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
16.7%
5/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Injury, poisoning and procedural complications
Tooth avulsion
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
3/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
25.0%
2/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
19.0%
8/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.5%
3/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.9%
4/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
25.0%
10/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
5/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.4%
3/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.5%
4/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
4/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
4/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
11.9%
5/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.5%
4/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Platelet count increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Investigations
Weight increased
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
3/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
4/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
11.9%
5/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
4/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
25.0%
2/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.5%
4/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
20.0%
8/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.2%
2/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
3/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
5.0%
2/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.2%
2/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
5.0%
2/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.2%
2/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
5.0%
2/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
15.6%
5/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.2%
2/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
16.1%
5/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
5.0%
2/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Monoparesis
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Psychiatric disorders
Distractibility
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.5%
3/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.4%
3/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Renal and urinary disorders
Ketonuria
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.5%
3/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.2%
2/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.4%
1/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
10.0%
4/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
9.7%
3/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.2%
2/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
7.1%
3/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.3%
1/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
4.8%
2/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
2.5%
1/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.5%
2/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.1%
1/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.7%
2/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
33.3%
1/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
6.2%
2/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
|
Vascular disorders
White coat hypertension
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/3 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
12.5%
1/8 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/42 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/40 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
3.2%
1/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/32 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/30 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/31 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
0.00%
0/1 • From the start of treatment until the end of treatment + 42 days of residual effect period, up to 1263 days.
Treated set (TS): This patient set includes all patients enrolled in the trial who were documented to have received at least one dose of ezabenlimab or BI 836880.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER