Trial Outcomes & Findings for Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma (NCT NCT05218499)

NCT ID: NCT05218499

Last Updated: 2025-11-14

Results Overview

Progression-free survival (PFS) based on blinded central independent review. For each patient, PFS was defined as the time interval from randomization until tumor progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (solely based on blinded central independent review) or death from any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter. (Note: the appearance of one or more new lesions is also considered progression).

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2/PHASE3
• Target enrollment: 400 participants
• Primary outcome timeframe: Up to 20.6 months.
• Results posted on: 2025-11-14

Participant Flow

This was a randomized, active-controlled, open-label, global trial with a seamless Phase II part and Phase III part parallel design.

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	Brigimadlin 30 mg q3w Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 30 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).	Brigimadlin 45 mg q3w Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).	Doxorubicin Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
Overall Study STARTED	90	148	162
Overall Study Doxorubicin Patients Who Crossed Over to Brigimadlin 30 mg q3w	0	0	7
Overall Study Doxorubicin Patients Who Crossed Over to Brigimadlin 45 mg q3w	0	0	70
Overall Study COMPLETED	0	0	76
Overall Study NOT COMPLETED	90	148	86

Reasons for withdrawal

Measure	Brigimadlin 30 mg q3w Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 30 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).	Brigimadlin 45 mg q3w Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).	Doxorubicin Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
Overall Study Not treated	1	1	8
Overall Study Death	2	0	0
Overall Study Other than listed	3	7	10
Overall Study Protocol deviation	5	6	4
Overall Study Technical problems	0	1	0
Overall Study Burden of trial procedures	0	1	2
Overall Study Clinical disease progression	6	6	11
Overall Study Objective disease progression	44	61	42
Overall Study Adverse Event	11	36	9
Overall Study On treatment at time of snapshot	18	29	0

Baseline Characteristics

Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma

Baseline characteristics by cohort

Measure	Brigimadlin 30 mg q3w n=90 Participants Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 30 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).	Brigimadlin 45 mg q3w n=148 Participants Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).	Doxorubicin n=162 Participants Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).	Total n=400 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Not Hispanic or Latino	79 Participants n=10 Participants	138 Participants n=10 Participants	150 Participants n=20 Participants	367 Participants n=45 Participants
Age, Continuous	62.3 years STANDARD_DEVIATION 11.7 • n=10 Participants	64.7 years STANDARD_DEVIATION 9.8 • n=10 Participants	63.0 years STANDARD_DEVIATION 11.7 • n=20 Participants	63.5 years STANDARD_DEVIATION 11.0 • n=45 Participants
Sex: Female, Male Female	35 Participants n=10 Participants	52 Participants n=10 Participants	62 Participants n=20 Participants	149 Participants n=45 Participants
Sex: Female, Male Male	55 Participants n=10 Participants	96 Participants n=10 Participants	100 Participants n=20 Participants	251 Participants n=45 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=10 Participants	6 Participants n=10 Participants	9 Participants n=20 Participants	23 Participants n=45 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=10 Participants	4 Participants n=10 Participants	3 Participants n=20 Participants	10 Participants n=45 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	1 Participants n=45 Participants
Race/Ethnicity, Customized Asian	20 Participants n=10 Participants	39 Participants n=10 Participants	29 Participants n=20 Participants	88 Participants n=45 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=10 Participants	1 Participants n=10 Participants	2 Participants n=20 Participants	4 Participants n=45 Participants
Race/Ethnicity, Customized White	65 Participants n=10 Participants	103 Participants n=10 Participants	128 Participants n=20 Participants	296 Participants n=45 Participants
Race/Ethnicity, Customized Missing	3 Participants n=10 Participants	5 Participants n=10 Participants	3 Participants n=20 Participants	11 Participants n=45 Participants

PRIMARY outcome

Timeframe: Up to 20.6 months.

Population: Randomised Set (RS): All patients randomized, regardless of whether they have received any trial medication or not.

Progression-free survival (PFS) based on blinded central independent review. For each patient, PFS was defined as the time interval from randomization until tumor progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (solely based on blinded central independent review) or death from any cause, whichever occurs first.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Doxorubicin n=162 Participants Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).	Brigimadlin 45 mg q3w n=90 Participants Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).	Doxorubicin n=148 Participants Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
Progression-free Survival (PFS)	7.16 Months Interval 2.63 to 11.33	8.18 Months Interval 2.96 to 16.66	8.38 Months Interval 3.94 to Not evaluable: not enough events reached.

SECONDARY outcome

Timeframe: Up to 20.6 months.

Population: Randomised Set (RS): All patients randomized, regardless of whether they have received any trial medication or not.

Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1 (based on blinded central independent review) from the date of randomization until disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Doxorubicin n=162 Participants Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).	Brigimadlin 45 mg q3w n=90 Participants Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).	Doxorubicin n=148 Participants Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
Objective Response (OR)	14 Participants	13 Participants	33 Participants

SECONDARY outcome

Timeframe: Up to 20.6 months.

Population: All patients randomized who had an objective response.

Duration of objective response (DOR), defined as the time interval from first documented confirmed OR until disease progression or death among patients with confirmed OR (based on blinded central independent review), whichever occurs first.

Outcome measures

Measure	Doxorubicin n=14 Participants Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).	Brigimadlin 45 mg q3w n=13 Participants Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).	Doxorubicin n=33 Participants Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
Duration of Objective Response (DOR)	9.99 Months Interval 9.89 to 15.41	NA Months Interval 8.51 to Not enough participants with events.	9.92 Months Interval 9.72 to Not enough participants with events.

SECONDARY outcome

Timeframe: Up to 20.6 months.

Population: Randomised Set (RS): All patients randomized, regardless of whether they have received any trial medication or not.

Disease control (DC), defined as a best overall response of CR, PR, or stable disease (SD) according to RECIST version 1.1 (based on blinded central independent review).

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Outcome measures

Measure	Doxorubicin n=162 Participants Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).	Brigimadlin 45 mg q3w n=90 Participants Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).	Doxorubicin n=148 Participants Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
Disease Control (DC)	117 Participants	71 Participants	128 Participants

SECONDARY outcome

Timeframe: Baseline (cycle 1 day 1), week 6 and week 18.

Population: Randomised Set (RS). As per protocol, the endpoint was performed as part of the Phase III of the trial, which only includes the selected investigational arm (brigimadlin 45 mg q3w) and the doxorubicin control arm.

Mean change from baseline to week 6 and 18 in the following European Organization for Research and Treatment on Cancer (EORTC) Quality of Life Core Questionnaire 30 items (QLQ-C30) scores:

• Physical functioning (higher score is better)
• Pain (higher score is worse)
• Fatigue (higher score is worse)
• Global health status / QoL (higher score is better)

and the following scores obtained using items from the EORTC QLQ-C30 and EORTC Item Library (higher score is worse):

• Fatigue symptoms
• Fatigability
• Fatigue impact
• Pain descriptors
• Pain impact

All of the scales and single-item measures range in score from 0 to 100.

Outcome measures

Measure	Doxorubicin Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).	Brigimadlin 45 mg q3w n=121 Participants Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).	Doxorubicin n=114 Participants Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).
Change in Health-Related Quality of Life at Week 6 and 18 Physical functioning - Change from baseline at Week 6	—	-2.1 Score on a scale Standard Deviation 17.4	-5.5 Score on a scale Standard Deviation 17.9
Change in Health-Related Quality of Life at Week 6 and 18 Physical functioning - Change from baseline at Week 18	—	-5.9 Score on a scale Standard Deviation 20.8	-7.5 Score on a scale Standard Deviation 16.3
Change in Health-Related Quality of Life at Week 6 and 18 Pain - Change from baseline at Week 6	—	-3.7 Score on a scale Standard Deviation 20.2	0.8 Score on a scale Standard Deviation 25.2
Change in Health-Related Quality of Life at Week 6 and 18 Pain - Change from baseline at Week 18	—	1.4 Score on a scale Standard Deviation 26.0	-1.0 Score on a scale Standard Deviation 26.7
Change in Health-Related Quality of Life at Week 6 and 18 Fatigue - Change from baseline at Week 6	—	3.4 Score on a scale Standard Deviation 21.2	10.5 Score on a scale Standard Deviation 23.5
Change in Health-Related Quality of Life at Week 6 and 18 Fatigue - Change from baseline at Week 18	—	8.1 Score on a scale Standard Deviation 27.5	14.1 Score on a scale Standard Deviation 27.5
Change in Health-Related Quality of Life at Week 6 and 18 Global health status / quality of life - Change from baseline at Week 6	—	-0.6 Score on a scale Standard Deviation 18.6	-8.9 Score on a scale Standard Deviation 22.4
Change in Health-Related Quality of Life at Week 6 and 18 Global health status / quality of life - Change from baseline at Week 18	—	-5.8 Score on a scale Standard Deviation 24.5	-8.0 Score on a scale Standard Deviation 20.8
Change in Health-Related Quality of Life at Week 6 and 18 Fatigue symptoms - Change from baseline at Week 6	—	3.4 Score on a scale Standard Deviation 19.2	10.6 Score on a scale Standard Deviation 25.1
Change in Health-Related Quality of Life at Week 6 and 18 Fatigue symptoms - Change from baseline at Week 18	—	7.9 Score on a scale Standard Deviation 26.7	14.7 Score on a scale Standard Deviation 26.2
Change in Health-Related Quality of Life at Week 6 and 18 Fatigability - Change from baseline at Week 6	—	3.3 Score on a scale Standard Deviation 19.8	11.2 Score on a scale Standard Deviation 21.8
Change in Health-Related Quality of Life at Week 6 and 18 Fatigability - Change from baseline at Week 18	—	5.1 Score on a scale Standard Deviation 23.3	16.4 Score on a scale Standard Deviation 24.3
Change in Health-Related Quality of Life at Week 6 and 18 Fatigue impact - Change from baseline at Week 6	—	-1.5 Score on a scale Standard Deviation 20.5	3.5 Score on a scale Standard Deviation 23.7
Change in Health-Related Quality of Life at Week 6 and 18 Fatigue impact - Change from baseline at Week 18	—	1.6 Score on a scale Standard Deviation 23.5	6.2 Score on a scale Standard Deviation 25.9
Change in Health-Related Quality of Life at Week 6 and 18 Pain descriptors - Change from baseline at Week 6	—	-2.7 Score on a scale Standard Deviation 18.5	0.9 Score on a scale Standard Deviation 16.5
Change in Health-Related Quality of Life at Week 6 and 18 Pain descriptors - Change from baseline at Week 18	—	0.4 Score on a scale Standard Deviation 24.1	1.8 Score on a scale Standard Deviation 17.7
Change in Health-Related Quality of Life at Week 6 and 18 Pain impact - Change from baseline at Week 6	—	-3.0 Score on a scale Standard Deviation 14.7	1.9 Score on a scale Standard Deviation 18.9
Change in Health-Related Quality of Life at Week 6 and 18 Pain impact - Change from baseline at Week 18	—	0.6 Score on a scale Standard Deviation 19.6	2.4 Score on a scale Standard Deviation 20.5

Adverse Events

Brigimadlin 30 mg q3w

Serious events: 27 serious events

Other events: 89 other events

Deaths: 31 deaths

Brigimadlin 45 mg q3w

Serious events: 57 serious events

Other events: 144 other events

Deaths: 40 deaths

Doxorubicin

Serious events: 42 serious events

Other events: 153 other events

Deaths: 15 deaths

Doxorubicin - Brigimadlin 30 mg q3w

Serious events: 1 serious events

Other events: 6 other events

Deaths: 5 deaths

Doxorubicin - Brigimadlin 45 mg q3w

Serious events: 22 serious events

Other events: 67 other events

Deaths: 22 deaths

Serious adverse events

Measure	Brigimadlin 30 mg q3w n=89 participants at risk Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 30 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).	Brigimadlin 45 mg q3w n=147 participants at risk Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).	Doxorubicin n=154 participants at risk Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).	Doxorubicin - Brigimadlin 30 mg q3w n=7 participants at risk Patients on Doxorubicin with a confirmed disease progression who crossed to Brigimadlin 30 mg taken orally on day 1 of each 21-day cycle (q3w).	Doxorubicin - Brigimadlin 45 mg q3w n=70 participants at risk Patients on Doxorubicin with a confirmed disease progression who crossed to Brigimadlin 45 mg taken orally on day 1 of each 21-day cycle (q3w).
Blood and lymphatic system disorders Anaemia	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.8% 7/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.3% 2/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.3% 3/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Blood and lymphatic system disorders Febrile neutropenia	2.2% 2/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	7.8% 12/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Blood and lymphatic system disorders Myelosuppression	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Blood and lymphatic system disorders Neutropenia	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 2/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.3% 2/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Blood and lymphatic system disorders Thrombocytopenia	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.1% 6/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.3% 2/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Cardiac disorders Angina unstable	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Cardiac disorders Atrial fibrillation	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Cardiac disorders Bradycardia	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Cardiac disorders Pericarditis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Cardiac disorders Tachyarrhythmia	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Endocrine disorders Adrenal insufficiency	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Abdominal pain	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.3% 3/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Abdominal pain upper	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Duodenal stenosis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Pain	2.2% 2/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Dyspepsia	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Gastric perforation	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Ileus	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Inguinal hernia	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Intestinal obstruction	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Large intestine perforation	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Melaena	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Mesenteric vein thrombosis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Nausea	2.2% 2/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 2/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Obstruction gastric	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Pancreatitis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Stomatitis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Vomiting	2.2% 2/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Chest pain	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Condition aggravated	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Disease progression	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.9% 2/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Fatigue	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 2/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders General physical health deterioration	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Hyperthermia	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Infusion site phlebitis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Malaise	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Mucosal inflammation	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Oedema peripheral	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Pyrexia	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 2/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.6% 4/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Hepatobiliary disorders Cholangitis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Hepatobiliary disorders Cholecystitis	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Hepatobiliary disorders Cholestasis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Hepatobiliary disorders Hepatic failure	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Hepatobiliary disorders Liver injury	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations COVID-19	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Cellulitis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Clostridium difficile infection	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.3% 2/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Cytomegalovirus viraemia	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Device related infection	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Diverticulitis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Focal peritonitis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Fungaemia	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Neutropenic sepsis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Phlebitis infective	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Pneumocystis jirovecii infection	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Pneumonia	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.0% 3/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.3% 2/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Pneumonia necrotising	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Respiratory tract infection	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Sepsis	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 2/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Stoma site infection	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Subcutaneous abscess	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Urinary tract infection	2.2% 2/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Injury, poisoning and procedural complications Femur fracture	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Injury, poisoning and procedural complications Humerus fracture	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Investigations Blood creatinine increased	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Investigations Neutrophil count decreased	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	3.4% 5/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.6% 4/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Investigations Platelet count decreased	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	8.2% 12/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.3% 2/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Investigations Troponin I increased	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Investigations White blood cell count decreased	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.9% 3/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Metabolism and nutrition disorders Dehydration	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Metabolism and nutrition disorders Hyperglycaemia	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Nervous system disorders Epilepsy	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour fistulisation	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Nervous system disorders Cerebral infarction	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 2/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Nervous system disorders Haemorrhage intracranial	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Nervous system disorders Hemiparesis	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Nervous system disorders Hypoglycaemic seizure	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Nervous system disorders Ischaemic stroke	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Nervous system disorders Seizure	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Nervous system disorders Syncope	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 2/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Product Issues Device physical property issue	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Psychiatric disorders Anxiety	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Psychiatric disorders Delirium	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Renal and urinary disorders Acute kidney injury	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Renal and urinary disorders Hydronephrosis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Renal and urinary disorders Obstructive nephropathy	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Renal and urinary disorders Renal failure	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Renal and urinary disorders Renal vein embolism	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Renal and urinary disorders Urinary retention	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Reproductive system and breast disorders Ovarian vein thrombosis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.3% 2/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.2% 2/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.4% 3/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.8% 7/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.5% 7/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Surgical and medical procedures Assisted suicide	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Vascular disorders Aortic thrombosis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 2/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Vascular disorders Deep vein thrombosis	2.2% 2/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.0% 3/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.3% 2/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.9% 2/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Vascular disorders Embolism	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.7% 4/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Vascular disorders Embolism arterial	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Vascular disorders Haematoma	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Vascular disorders Hypotension	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Vascular disorders Iliac artery occlusion	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Vascular disorders Pelvic venous thrombosis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Vascular disorders Peripheral artery occlusion	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Vascular disorders Peripheral embolism	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Vascular disorders Peripheral ischaemia	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Vascular disorders Superficial vein thrombosis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Vascular disorders Vasculitis	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).

Other adverse events

Measure	Brigimadlin 30 mg q3w n=89 participants at risk Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 30 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).	Brigimadlin 45 mg q3w n=147 participants at risk Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received 45 milligram (mg) brigimadlin taken orally on day 1 of each 21-day cycle (q3w).	Doxorubicin n=154 participants at risk Patients with advanced or metastatic dedifferentiated liposarcoma (DDLPS) received one intravenous infusion of 75 milligram per square meter (mg/m2) on Day 1 of each 21-day cycle (q3w) until a maximum cumulative dose of 450 mg/m2 (approximately 6 cycles).	Doxorubicin - Brigimadlin 30 mg q3w n=7 participants at risk Patients on Doxorubicin with a confirmed disease progression who crossed to Brigimadlin 30 mg taken orally on day 1 of each 21-day cycle (q3w).	Doxorubicin - Brigimadlin 45 mg q3w n=70 participants at risk Patients on Doxorubicin with a confirmed disease progression who crossed to Brigimadlin 45 mg taken orally on day 1 of each 21-day cycle (q3w).
Blood and lymphatic system disorders Neutropenia	18.0% 16/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	28.6% 42/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	31.8% 49/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	18.6% 13/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Blood and lymphatic system disorders Leukopenia	2.2% 2/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	10.2% 15/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	13.6% 21/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.3% 3/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Blood and lymphatic system disorders Lymphopenia	2.2% 2/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.7% 4/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	3.9% 6/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	7.1% 5/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Blood and lymphatic system disorders Anaemia	24.7% 22/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	35.4% 52/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	40.9% 63/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	31.4% 22/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Blood and lymphatic system disorders Thrombocytopenia	22.5% 20/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	27.2% 40/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	6.5% 10/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	21.4% 15/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Cardiac disorders Palpitations	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.7% 4/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.3% 2/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.7% 4/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Ear and labyrinth disorders Hypoacusis	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Eye disorders Visual impairment	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Abdominal distension	5.6% 5/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.8% 7/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.9% 3/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.9% 2/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Pyrexia	12.4% 11/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	6.1% 9/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	13.6% 21/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	28.6% 2/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	11.4% 8/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Abdominal pain	20.2% 18/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	19.0% 28/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	11.7% 18/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	20.0% 14/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Abdominal pain upper	11.2% 10/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.8% 7/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.8% 9/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.9% 2/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Constipation	22.5% 20/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	17.7% 26/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	24.0% 37/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	15.7% 11/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Diarrhoea	39.3% 35/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	40.8% 60/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	27.3% 42/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	28.6% 2/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	34.3% 24/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Dry mouth	3.4% 3/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.4% 8/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.9% 3/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.3% 3/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Dyspepsia	13.5% 12/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.4% 8/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	7.1% 11/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.9% 2/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Gastrooesophageal reflux disease	3.4% 3/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.4% 8/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	3.9% 6/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Nausea	79.8% 71/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	76.2% 112/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	58.4% 90/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	57.1% 4/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	65.7% 46/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Stomatitis	2.2% 2/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.8% 7/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	21.4% 33/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.7% 4/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Gastrointestinal disorders Vomiting	52.8% 47/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	37.4% 55/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	18.2% 28/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	28.6% 2/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	30.0% 21/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Asthenia	32.6% 29/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	21.8% 32/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	26.0% 40/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	25.7% 18/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Fatigue	33.7% 30/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	44.2% 65/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	36.4% 56/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	42.9% 3/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	25.7% 18/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Influenza like illness	2.2% 2/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	3.4% 5/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.3% 2/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.7% 4/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Malaise	7.9% 7/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	9.5% 14/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	7.8% 12/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	7.1% 5/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Mucosal inflammation	2.2% 2/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.8% 7/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 22/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.9% 2/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Oedema peripheral	12.4% 11/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	9.5% 14/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	7.1% 11/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	10.0% 7/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
General disorders Pain	6.7% 6/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.1% 6/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.9% 3/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.3% 3/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations COVID-19	12.4% 11/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.4% 8/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.5% 7/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.9% 2/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Nasopharyngitis	9.0% 8/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	3.4% 5/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.9% 3/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.9% 2/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Upper respiratory tract infection	3.4% 3/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	3.4% 5/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.5% 7/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Infections and infestations Urinary tract infection	9.0% 8/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	8.2% 12/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	3.9% 6/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.7% 4/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Investigations Alanine aminotransferase increased	5.6% 5/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	6.1% 9/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.5% 7/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.9% 2/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Investigations Blood alkaline phosphatase increased	4.5% 4/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 2/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.9% 3/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.7% 4/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Investigations Blood cholesterol increased	2.2% 2/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Investigations Blood creatinine increased	3.4% 3/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	8.2% 12/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	3.2% 5/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	8.6% 6/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Investigations Lymphocyte count decreased	5.6% 5/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	8.8% 13/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	3.2% 5/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.7% 4/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Investigations Neutrophil count decreased	28.1% 25/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	32.7% 48/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	20.1% 31/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	24.3% 17/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Investigations Platelet count decreased	28.1% 25/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	29.3% 43/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	8.4% 13/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	21.4% 15/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Investigations Weight decreased	5.6% 5/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	10.9% 16/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	6.5% 10/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.3% 3/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Investigations Weight increased	3.4% 3/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	3.4% 5/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.3% 2/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.7% 4/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Investigations White blood cell count decreased	18.0% 16/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	13.6% 20/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	13.6% 21/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	15.7% 11/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Metabolism and nutrition disorders Decreased appetite	39.3% 35/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	46.3% 68/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	26.6% 41/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	42.9% 3/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	38.6% 27/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Metabolism and nutrition disorders Hypoalbuminaemia	4.5% 4/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	6.1% 9/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	7.1% 11/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.3% 3/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Metabolism and nutrition disorders Hypocalcaemia	4.5% 4/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.0% 3/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	3.2% 5/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.7% 4/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Metabolism and nutrition disorders Hypokalaemia	3.4% 3/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	6.1% 9/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	7.1% 11/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	8.6% 6/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Metabolism and nutrition disorders Hypomagnesaemia	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 2/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	3.2% 5/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.7% 4/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Metabolism and nutrition disorders Hyponatraemia	4.5% 4/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	6.8% 10/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.5% 7/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Metabolism and nutrition disorders Hypophosphataemia	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 2/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	3.2% 5/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.7% 4/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Musculoskeletal and connective tissue disorders Arthralgia	10.1% 9/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	11.6% 17/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.8% 9/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.7% 4/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Musculoskeletal and connective tissue disorders Back pain	11.2% 10/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	8.8% 13/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	7.8% 12/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.7% 4/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.9% 2/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Musculoskeletal and connective tissue disorders Myalgia	3.4% 3/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.4% 8/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	3.9% 6/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.7% 4/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Nervous system disorders Dizziness	13.5% 12/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	7.5% 11/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	6.5% 10/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	7.1% 5/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Nervous system disorders Dysgeusia	21.3% 19/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	27.2% 40/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	16.9% 26/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	12.9% 9/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Nervous system disorders Headache	7.9% 7/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	10.2% 15/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	9.7% 15/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	10.0% 7/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Nervous system disorders Taste disorder	4.5% 4/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	3.4% 5/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.3% 2/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Psychiatric disorders Depressed mood	1.1% 1/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.68% 1/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Psychiatric disorders Insomnia	7.9% 7/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	12.9% 19/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	3.2% 5/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	1.4% 1/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Renal and urinary disorders Dysuria	0.00% 0/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.7% 4/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.65% 1/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Respiratory, thoracic and mediastinal disorders Cough	16.9% 15/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	13.6% 20/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.8% 9/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	10.0% 7/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.1% 9/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	10.2% 15/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	3.9% 6/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	14.3% 1/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	10.0% 7/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Respiratory, thoracic and mediastinal disorders Hiccups	4.5% 4/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	12.9% 19/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	5.2% 8/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	2.9% 2/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Skin and subcutaneous tissue disorders Alopecia	13.5% 12/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	21.8% 32/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	43.5% 67/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	7.1% 5/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).
Vascular disorders Hypertension	3.4% 3/89 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	8.2% 12/147 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	3.9% 6/154 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	0.00% 0/7 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).	4.3% 3/70 • Up to approximately 20.8 months. This patient set includes all patients who were documented to have taken at least one dose of trial medication (brigimadlin or doxorubicin).

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

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.
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Restriction type: OTHER