Trial Outcomes & Findings for Navtemadlin and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma (NCT NCT03217266)

NCT ID: NCT03217266

Last Updated: 2025-09-23

Results Overview

Dose was determined separately for each cohort using the classic 3+3 design to determine the safety of each dose level from the number of participants with dose limiting toxicities (DLTs), starting with dose level 1. If dose level 1 were considered unsafe, a lower dose level of twice/week would be tested. The highest dose level deemed safe is considered the MTD. Five additional patients were accrued to the MTD to ensure safety. A DLT is defined as any grade 4-5 adverse event (AE) using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) that was definitely, probably, or possibly (DPP) related to navtemadlin or combined navtemadlin+RT ≤ 4 weeks after completing navtemadlin. Any grade 3 AE DPP related to navtemadlin/navtemadlin+RT was also considered a DLT if due to the grade 3 AE there was a delay of \>2 weeks or if there were ≥ 2 dose reductions. CTCAE 5.0 Grade 3 is a severe AE, Grade 4 is a life-threatening or disabling AE, and Grade 5 results in death.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 39 participants
• Primary outcome timeframe: Baseline to end of navtemadlin + 4 weeks (approximately 10 weeks total)
• Results posted on: 2025-09-23

Participant Flow

This is a two-step study in which all participants start one week of treatment at Step 1 at the current dose escalation level while p53 status is determined, but Step 2 assigns the full/remaining course of treatment and determines the intended analysis population: participants with wild-type p53 (Group I) continue on navtemadlin for the purpose of the study analysis, while the rest of participants (Group II) discontinue navtemadlin and are not included in endpoint analyses.

Participant milestones

Measure	Step 1 (Tumor Tissue Testing, Navtemadlin): Cohort A Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Cohort A = Patients with extremity/body wall soft tissue sarcoma. Dose escalates separately within each cohort.	Step 1 (Tumor Tissue Testing, Navtemadlin): Cohort B Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-5 of week 1 in the absence of disease progression or unacceptable toxicity. Cohort A = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma. Dose escalates separately within each cohort.	Step 2: Group I (Navtemadlin, Radiation Therapy, Surgery) Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy (RT) daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group I = Wild-type p53 status determined by testing in Step 1. (Both cohorts)	Step 2: Group II (Radiation Therapy, Surgery) Starting with week 2, patients undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group II = Mutant or unknown p53 status determined by testing in Step 1. (Both cohorts.)
Total Enrollment to Step 1 STARTED	27	12	0	0
Total Enrollment to Step 1 COMPLETED	27	12	0	0
Total Enrollment to Step 1 NOT COMPLETED	0	0	0	0
Step 1: Dose Level 1 STARTED	4	5	0	0
Step 1: Dose Level 1 Eligible	4	5	0	0
Step 1: Dose Level 1 Started Treatment	3	5	0	0
Step 1: Dose Level 1 Determined to Have Wild-type p53 (Group I)	3	3	0	0
Step 1: Dose Level 1 Determined to Have Mutant or Unknown p53 (Group II)	0	2	0	0
Step 1: Dose Level 1 COMPLETED	3	5	0	0
Step 1: Dose Level 1 NOT COMPLETED	1	0	0	0
Step 1: Dose Level 2 STARTED	7	7	0	0
Step 1: Dose Level 2 Eligible	7	7	0	0
Step 1: Dose Level 2 Started Treatment	6	5	0	0
Step 1: Dose Level 2 Determined to Have Wild-type p53 (Group I)	4	3	0	0
Step 1: Dose Level 2 Determined to Have Mutant or Unknown p53 (Group II)	2	2	0	0
Step 1: Dose Level 2 COMPLETED	6	5	0	0
Step 1: Dose Level 2 NOT COMPLETED	1	2	0	0
Step 1: Dose Level 3 STARTED	16	0	0	0
Step 1: Dose Level 3 Eligible	16	0	0	0
Step 1: Dose Level 3 Started Treatment	15	0	0	0
Step 1: Dose Level 3 Determined to Have Wild-type p53 (Group I)	9	0	0	0
Step 1: Dose Level 3 Determined to Have Mutant or Unknown p53 (Group II)	6	0	0	0
Step 1: Dose Level 3 COMPLETED	15	0	0	0
Step 1: Dose Level 3 NOT COMPLETED	1	0	0	0
Step 2 STARTED	0	0	22	12
Step 2 AE Reporting	0	0	22	12
Step 2 Protocol Endpoint Reporting	0	0	22	0
Step 2 COMPLETED	0	0	22	12
Step 2 NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Measure	Step 1 (Tumor Tissue Testing, Navtemadlin): Cohort A Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Cohort A = Patients with extremity/body wall soft tissue sarcoma. Dose escalates separately within each cohort.	Step 1 (Tumor Tissue Testing, Navtemadlin): Cohort B Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-5 of week 1 in the absence of disease progression or unacceptable toxicity. Cohort A = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma. Dose escalates separately within each cohort.	Step 2: Group I (Navtemadlin, Radiation Therapy, Surgery) Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy (RT) daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group I = Wild-type p53 status determined by testing in Step 1. (Both cohorts)	Step 2: Group II (Radiation Therapy, Surgery) Starting with week 2, patients undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group II = Mutant or unknown p53 status determined by testing in Step 1. (Both cohorts.)
Step 1: Dose Level 1 Did not start protocol treatment	1	0	0	0
Step 1: Dose Level 2 Did not start protocol treatment	1	2	0	0
Step 1: Dose Level 3 Did not start treatment	1	0	0	0

Baseline Characteristics

One participant's tissue was not centrally reviewed.

Baseline characteristics by cohort

Measure	Group I: Cohort A: Dose Level 1 (3x/Week) n=3 Participants Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. (Step 1) Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group I = wild-type p53 status. Cohort A = Patients with extremity/body wall soft tissue sarcoma.	Group I: Dose Level 2 (4x/Week) n=4 Participants Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-5 of week 1 in the absence of disease progression or unacceptable toxicity. (Step 1) Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group I = wild-type p53 status. Cohort A = Patients with extremity/body wall soft tissue sarcoma.	Group I: Cohort A: Dose Level 3 (5x/Week) n=9 Participants Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 1-5 of week 1 in the absence of disease progression or unacceptable toxicity. (Step 1) Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group I = wild-type p53 status. Cohort A = Patients with extremity/body wall soft tissue sarcoma.wall soft tissue sarcoma.	Group I: Cohort B: Dose Level 1 (3x/Week) n=3 Participants Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. (Step 1) Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group I = wild-type p53 status. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.	Group I: Cohort B: Dose Level 2 (4x/Week) n=3 Participants Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-5 of week 1 in the absence of disease progression or unacceptable toxicity. (Step 1) Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group I = wild-type p53 status. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.	Group II: Cohort A: Level 2 (4x/Week) n=2 Participants Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-5 of week 1 in the absence of disease progression or unacceptable toxicity. Starting with week 2, patients undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group II = mutant or unknown p53 status. Cohort A = Patients with extremity/body wall soft tissue sarcoma.	Group II: Cohort A: Dose Level 3 (5x/Week) n=6 Participants Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 1-5 of week 1 in the absence of disease progression or unacceptable toxicity. Starting with week 2, patients undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group II = mutant or unknown p53 status. Cohort A = Patients with extremity/body wall soft tissue sarcoma.	Group II: Cohort B: Dose Level 1 (3x/Week) n=2 Participants Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Starting with week 2, patients undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group II = mutant or unknown p53 status. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.	Group II: Cohort B: Dose Level 2 (4x/Week) n=2 Participants Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-5 of week 1 in the absence of disease progression or unacceptable toxicity. Starting with week 2, patients undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group II = mutant or unknown p53 status. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.	Total n=34 Participants Total of all reporting groups
Age, Customized ≤ 49 years	0 Participants n=3 Participants	0 Participants n=4 Participants	4 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	1 Participants n=6 Participants	0 Participants n=2 Participants	1 Participants n=2 Participants	6 Participants n=34 Participants
Age, Customized 50 - 59 years	0 Participants n=3 Participants	0 Participants n=4 Participants	1 Participants n=9 Participants	1 Participants n=3 Participants	0 Participants n=3 Participants	2 Participants n=2 Participants	1 Participants n=6 Participants	0 Participants n=2 Participants	1 Participants n=2 Participants	6 Participants n=34 Participants
Age, Customized 60 -69 years	3 Participants n=3 Participants	4 Participants n=4 Participants	1 Participants n=9 Participants	2 Participants n=3 Participants	2 Participants n=3 Participants	0 Participants n=2 Participants	3 Participants n=6 Participants	1 Participants n=2 Participants	0 Participants n=2 Participants	16 Participants n=34 Participants
Age, Customized ≥ 70 years	0 Participants n=3 Participants	0 Participants n=4 Participants	3 Participants n=9 Participants	0 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=2 Participants	1 Participants n=6 Participants	1 Participants n=2 Participants	0 Participants n=2 Participants	6 Participants n=34 Participants
Sex: Female, Male Female	1 Participants n=3 Participants	1 Participants n=4 Participants	6 Participants n=9 Participants	2 Participants n=3 Participants	1 Participants n=3 Participants	2 Participants n=2 Participants	4 Participants n=6 Participants	1 Participants n=2 Participants	1 Participants n=2 Participants	19 Participants n=34 Participants
Sex: Female, Male Male	2 Participants n=3 Participants	3 Participants n=4 Participants	3 Participants n=9 Participants	1 Participants n=3 Participants	2 Participants n=3 Participants	0 Participants n=2 Participants	2 Participants n=6 Participants	1 Participants n=2 Participants	1 Participants n=2 Participants	15 Participants n=34 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	1 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants	0 Participants n=2 Participants	0 Participants n=2 Participants	1 Participants n=34 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=3 Participants	4 Participants n=4 Participants	8 Participants n=9 Participants	2 Participants n=3 Participants	3 Participants n=3 Participants	2 Participants n=2 Participants	5 Participants n=6 Participants	2 Participants n=2 Participants	2 Participants n=2 Participants	31 Participants n=34 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	0 Participants n=4 Participants	1 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	1 Participants n=6 Participants	0 Participants n=2 Participants	0 Participants n=2 Participants	2 Participants n=34 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants	0 Participants n=2 Participants	0 Participants n=2 Participants	0 Participants n=34 Participants
Race (NIH/OMB) Asian	0 Participants n=3 Participants	0 Participants n=4 Participants	1 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants	0 Participants n=2 Participants	0 Participants n=2 Participants	1 Participants n=34 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants	0 Participants n=2 Participants	0 Participants n=2 Participants	0 Participants n=34 Participants
Race (NIH/OMB) Black or African American	0 Participants n=3 Participants	2 Participants n=4 Participants	1 Participants n=9 Participants	0 Participants n=3 Participants	2 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants	0 Participants n=2 Participants	1 Participants n=2 Participants	6 Participants n=34 Participants
Race (NIH/OMB) White	3 Participants n=3 Participants	2 Participants n=4 Participants	7 Participants n=9 Participants	3 Participants n=3 Participants	0 Participants n=3 Participants	2 Participants n=2 Participants	5 Participants n=6 Participants	2 Participants n=2 Participants	1 Participants n=2 Participants	25 Participants n=34 Participants
Race (NIH/OMB) More than one race	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants	0 Participants n=2 Participants	0 Participants n=2 Participants	0 Participants n=34 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=2 Participants	1 Participants n=6 Participants	0 Participants n=2 Participants	0 Participants n=2 Participants	2 Participants n=34 Participants
Zubrod performance status 0	0 Participants n=3 Participants	2 Participants n=4 Participants	7 Participants n=9 Participants	2 Participants n=3 Participants	2 Participants n=3 Participants	1 Participants n=2 Participants	5 Participants n=6 Participants	2 Participants n=2 Participants	1 Participants n=2 Participants	22 Participants n=34 Participants
Zubrod performance status 1	3 Participants n=3 Participants	2 Participants n=4 Participants	2 Participants n=9 Participants	1 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=2 Participants	1 Participants n=6 Participants	0 Participants n=2 Participants	1 Participants n=2 Participants	12 Participants n=34 Participants
Histology from Central Review Dedifferentiated liposarcoma	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=4 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=9 Participants • One participant's tissue was not centrally reviewed.	2 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	2 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=5 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	7 Participants n=33 Participants • One participant's tissue was not centrally reviewed.
Histology from Central Review Extraskeletal myxoid chondrosarcoma	1 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=4 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=9 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=5 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=33 Participants • One participant's tissue was not centrally reviewed.
Histology from Central Review Malignant peripheral nerve sheath tumor	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=4 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=9 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=5 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=33 Participants • One participant's tissue was not centrally reviewed.
Histology from Central Review Myxofibrosarcoma	2 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	2 Participants n=4 Participants • One participant's tissue was not centrally reviewed.	3 Participants n=9 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=5 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	8 Participants n=33 Participants • One participant's tissue was not centrally reviewed.
Histology from Central Review Myxoid liposarcoma	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=4 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=9 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=5 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=33 Participants • One participant's tissue was not centrally reviewed.
Histology from Central Review Synovial sarcoma	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=4 Participants • One participant's tissue was not centrally reviewed.	2 Participants n=9 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=5 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	2 Participants n=33 Participants • One participant's tissue was not centrally reviewed.
Histology from Central Review Undifferentiated pleomorphic sarcoma	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=4 Participants • One participant's tissue was not centrally reviewed.	2 Participants n=9 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	4 Participants n=5 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	7 Participants n=33 Participants • One participant's tissue was not centrally reviewed.
Histology from Central Review Undifferentiated spindle cell sarcoma	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=4 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=9 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=5 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=33 Participants • One participant's tissue was not centrally reviewed.
Histology from Central Review Leiomyosarcoma	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=4 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=9 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=5 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=33 Participants • One participant's tissue was not centrally reviewed.
Histology from Central Review Solitary fibrous tumor	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=4 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=9 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=5 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=33 Participants • One participant's tissue was not centrally reviewed.
Histology from Central Review Liposarcoma, not otherwise specified	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=4 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=9 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=5 Participants • One participant's tissue was not centrally reviewed.	2 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	3 Participants n=33 Participants • One participant's tissue was not centrally reviewed.
Histologic Grade from Central Review Grade II	2 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=4 Participants • One participant's tissue was not centrally reviewed.	2 Participants n=9 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	2 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=5 Participants • One participant's tissue was not centrally reviewed.	0 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	8 Participants n=33 Participants • One participant's tissue was not centrally reviewed.
Histologic Grade from Central Review Grade III	1 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	4 Participants n=4 Participants • One participant's tissue was not centrally reviewed.	7 Participants n=9 Participants • One participant's tissue was not centrally reviewed.	2 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=3 Participants • One participant's tissue was not centrally reviewed.	2 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	5 Participants n=5 Participants • One participant's tissue was not centrally reviewed.	2 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	1 Participants n=2 Participants • One participant's tissue was not centrally reviewed.	25 Participants n=33 Participants • One participant's tissue was not centrally reviewed.
Primary tumor site Back	0 Participants n=3 Participants	1 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants	0 Participants n=2 Participants	0 Participants n=2 Participants	1 Participants n=34 Participants
Primary tumor site Buttock	0 Participants n=3 Participants	0 Participants n=4 Participants	1 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=2 Participants	0 Participants n=6 Participants	0 Participants n=2 Participants	0 Participants n=2 Participants	2 Participants n=34 Participants
Primary tumor site Distal Lower Extremity	1 Participants n=3 Participants	0 Participants n=4 Participants	2 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	2 Participants n=6 Participants	0 Participants n=2 Participants	0 Participants n=2 Participants	5 Participants n=34 Participants
Primary tumor site Distal Upper Extremity	1 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants	0 Participants n=2 Participants	0 Participants n=2 Participants	1 Participants n=34 Participants
Primary tumor site Proximal Lower Extremity	1 Participants n=3 Participants	3 Participants n=4 Participants	4 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	2 Participants n=6 Participants	0 Participants n=2 Participants	0 Participants n=2 Participants	10 Participants n=34 Participants
Primary tumor site Proximal Upper Extremity	0 Participants n=3 Participants	0 Participants n=4 Participants	2 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants	0 Participants n=2 Participants	0 Participants n=2 Participants	2 Participants n=34 Participants
Primary tumor site Abdomen	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	1 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants	1 Participants n=2 Participants	0 Participants n=2 Participants	2 Participants n=34 Participants
Primary tumor site Retroperitoneum	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	2 Participants n=3 Participants	3 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants	1 Participants n=2 Participants	1 Participants n=2 Participants	7 Participants n=34 Participants
Primary tumor site Pelvis	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants	0 Participants n=2 Participants	1 Participants n=2 Participants	1 Participants n=34 Participants
Primary tumor site Shoulder	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=2 Participants	2 Participants n=6 Participants	0 Participants n=2 Participants	0 Participants n=2 Participants	3 Participants n=34 Participants
Tumor size (cm) 5 - < 10 cm	2 Participants n=3 Participants	3 Participants n=4 Participants	2 Participants n=9 Participants	0 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=2 Participants	3 Participants n=6 Participants	0 Participants n=2 Participants	1 Participants n=2 Participants	12 Participants n=34 Participants
Tumor size (cm) 10 - < 15 cm	0 Participants n=3 Participants	1 Participants n=4 Participants	4 Participants n=9 Participants	2 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=2 Participants	3 Participants n=6 Participants	2 Participants n=2 Participants	0 Participants n=2 Participants	14 Participants n=34 Participants
Tumor size (cm) ≥ 15 cm	1 Participants n=3 Participants	0 Participants n=4 Participants	3 Participants n=9 Participants	1 Participants n=3 Participants	1 Participants n=3 Participants	1 Participants n=2 Participants	0 Participants n=6 Participants	0 Participants n=2 Participants	1 Participants n=2 Participants	8 Participants n=34 Participants

PRIMARY outcome

Timeframe: Baseline to end of navtemadlin + 4 weeks (approximately 10 weeks total)

Population: Eligible wild-type p53 participants who either received at least one dose of navtemadlin if there was a dose limiting toxicity (DLT), or, in the absence of DLT, received at least one fraction of RT and completed DLT observation period (4 weeks after completion of navtemadlin). Step 2 Group I participants (Group I = wild-type p53 status).

Dose was determined separately for each cohort using the classic 3+3 design to determine the safety of each dose level from the number of participants with dose limiting toxicities (DLTs), starting with dose level 1. If dose level 1 were considered unsafe, a lower dose level of twice/week would be tested. The highest dose level deemed safe is considered the MTD. Five additional patients were accrued to the MTD to ensure safety.

A DLT is defined as any grade 4-5 adverse event (AE) using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) that was definitely, probably, or possibly (DPP) related to navtemadlin or combined navtemadlin+RT ≤ 4 weeks after completing navtemadlin. Any grade 3 AE DPP related to navtemadlin/navtemadlin+RT was also considered a DLT if due to the grade 3 AE there was a delay of >2 weeks or if there were ≥ 2 dose reductions. CTCAE 5.0 Grade 3 is a severe AE, Grade 4 is a life-threatening or disabling AE, and Grade 5 results in death.

Outcome measures

Measure	Cohort A n=15 Participants All participants who received at least one dose of 120 mg navtemadlin PO either 3 times/week (Dose Level 1), 4 times/week (Dose Level 2), or 5 times/week (Dose Level 3). Planned dosing was for six weeks; 50 Gy RT over 5 weeks starting week 2 day 1; surgery 5-8 weeks after RT completion.	Cohort B n=6 Participants All participants who received at least one dose of 120 mg navtemadlin PO either 3 times/week (Dose Level 1), 4 times/week (Dose Level 2), or 5 times/week (Dose Level 3). Planned dosing was for six weeks; 50 Gy RT over 5 weeks starting week 2 day 1; surgery 5-8 weeks after RT completion.	Cohort A: Dose Level 3 (5x/Week) Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 1-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort A = Patients with extremity/body wall soft tissue sarcoma.wall soft tissue sarcoma.	Cohort B: Dose Level 1 (3x/Week) Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.	Cohort B: Dose Level 2 (4x/Week) Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.
Maximum Tolerated Dose (MTD) / Recommended Phase 2 Dosage for Each Cohort	5 times per week of 125mg PO	NA times per week of 125mg PO The study closed due to poor accrual during dose level 2 and therefore MTD could not be determined.	—	—	—

PRIMARY outcome

Timeframe: Baseline to end of navtemadlin + 4 weeks (approximately 10 weeks total)

Population: Eligible wild-type p53 participants who either received at least one dose of navtemadlin if there was a dose limiting toxicity (DLT), or, in the absence of DLT, received at least one fraction of RT and completed DLT observation period (4 weeks after completion of navtemadlin).

A DLT is defined as any grade 4-5 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) that was definitely, probably, or possibly related to navtemadlin or combined navtemadlin+RT up to 4 weeks after the completion of navtemadlin. Any grade 3 AE definitely, probably, or possibly related to navtemadlin or combined navtemadlin+RT was also considered DLT if any of the 2 following situations occurred: a delay of >2 weeks due to the grade 3 AE, or ≥ 2 dose reductions due to the grade 3 AE. CTCAE 5.0 Grade 3 is a severe AE, Grade 4 is a life-threatening or disabling AE, and Grade 5 results in death.

Outcome measures

Measure	Cohort A n=3 Participants All participants who received at least one dose of 120 mg navtemadlin PO either 3 times/week (Dose Level 1), 4 times/week (Dose Level 2), or 5 times/week (Dose Level 3). Planned dosing was for six weeks; 50 Gy RT over 5 weeks starting week 2 day 1; surgery 5-8 weeks after RT completion.	Cohort B n=4 Participants All participants who received at least one dose of 120 mg navtemadlin PO either 3 times/week (Dose Level 1), 4 times/week (Dose Level 2), or 5 times/week (Dose Level 3). Planned dosing was for six weeks; 50 Gy RT over 5 weeks starting week 2 day 1; surgery 5-8 weeks after RT completion.	Cohort A: Dose Level 3 (5x/Week) n=8 Participants Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 1-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort A = Patients with extremity/body wall soft tissue sarcoma.wall soft tissue sarcoma.	Cohort B: Dose Level 1 (3x/Week) n=3 Participants Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.	Cohort B: Dose Level 2 (4x/Week) n=3 Participants Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.
Number of Participants Who Experienced Dose-limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At time of surgery (approximately 11 to 14 weeks)

Population: Eligible Group I (wild-type p53) participants who started protocol treatment and had central pathological review of their final surgical resection specimen.

The evaluation for pathologic response will include a formal evaluation of percent necrosis according to the guidelines established for osteosarcoma and is determined by central pathological review.

Outcome measures

Measure	Cohort A n=3 Participants All participants who received at least one dose of 120 mg navtemadlin PO either 3 times/week (Dose Level 1), 4 times/week (Dose Level 2), or 5 times/week (Dose Level 3). Planned dosing was for six weeks; 50 Gy RT over 5 weeks starting week 2 day 1; surgery 5-8 weeks after RT completion.	Cohort B n=2 Participants All participants who received at least one dose of 120 mg navtemadlin PO either 3 times/week (Dose Level 1), 4 times/week (Dose Level 2), or 5 times/week (Dose Level 3). Planned dosing was for six weeks; 50 Gy RT over 5 weeks starting week 2 day 1; surgery 5-8 weeks after RT completion.	Cohort A: Dose Level 3 (5x/Week) n=8 Participants Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 1-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort A = Patients with extremity/body wall soft tissue sarcoma.wall soft tissue sarcoma.	Cohort B: Dose Level 1 (3x/Week) n=3 Participants Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.	Cohort B: Dose Level 2 (4x/Week) n=1 Participants Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.
Percent of Necrosis in Final Surgical Resection Specimen 76-99%	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Percent of Necrosis in Final Surgical Resection Specimen 50-75%	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Percent of Necrosis in Final Surgical Resection Specimen 25-49%	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Percent of Necrosis in Final Surgical Resection Specimen <25%	2 Participants	0 Participants	3 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: At time of surgery (approximately 11 to 14 weeks)

Population: Eligible Group I (wild-type p53) participants who started protocol treatment and had central pathological review of their final surgical resection specimen.

Pathologic complete response is defined as 100% necrosis and is determined by central pathology review.

Outcome measures

Measure	Cohort A n=3 Participants All participants who received at least one dose of 120 mg navtemadlin PO either 3 times/week (Dose Level 1), 4 times/week (Dose Level 2), or 5 times/week (Dose Level 3). Planned dosing was for six weeks; 50 Gy RT over 5 weeks starting week 2 day 1; surgery 5-8 weeks after RT completion.	Cohort B n=2 Participants All participants who received at least one dose of 120 mg navtemadlin PO either 3 times/week (Dose Level 1), 4 times/week (Dose Level 2), or 5 times/week (Dose Level 3). Planned dosing was for six weeks; 50 Gy RT over 5 weeks starting week 2 day 1; surgery 5-8 weeks after RT completion.	Cohort A: Dose Level 3 (5x/Week) n=8 Participants Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 1-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort A = Patients with extremity/body wall soft tissue sarcoma.wall soft tissue sarcoma.	Cohort B: Dose Level 1 (3x/Week) n=3 Participants Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.	Cohort B: Dose Level 2 (4x/Week) n=1 Participants Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.
Number of Participants With Pathologic Complete Response (PCR) in Final Surgical Resection Specimen	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to the date of failure or last known follow-up, up to 2.5 years from end of RT (six weeks).

Population: Eligible Group I (wild-type p53) participants who started protocol treatment.

Local failure (LF) was defined as local recurrence or progression after surgery, or amputation for treatment complications or recurrence/progression. In addition, any patient that did not have surgery was considered to have local failure. Local progression was defined as at lease 20% increase in the maximal dimension of the primary tumor taking as reference the smallest maximal dimension recorded since treatment started.

Outcome measures

Measure	Cohort A n=3 Participants All participants who received at least one dose of 120 mg navtemadlin PO either 3 times/week (Dose Level 1), 4 times/week (Dose Level 2), or 5 times/week (Dose Level 3). Planned dosing was for six weeks; 50 Gy RT over 5 weeks starting week 2 day 1; surgery 5-8 weeks after RT completion.	Cohort B n=4 Participants All participants who received at least one dose of 120 mg navtemadlin PO either 3 times/week (Dose Level 1), 4 times/week (Dose Level 2), or 5 times/week (Dose Level 3). Planned dosing was for six weeks; 50 Gy RT over 5 weeks starting week 2 day 1; surgery 5-8 weeks after RT completion.	Cohort A: Dose Level 3 (5x/Week) n=9 Participants Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 1-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort A = Patients with extremity/body wall soft tissue sarcoma.wall soft tissue sarcoma.	Cohort B: Dose Level 1 (3x/Week) n=3 Participants Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.	Cohort B: Dose Level 2 (4x/Week) n=3 Participants Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.
Number of Participants With Local Failure	1 Participants	2 Participants	2 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline to the date of disease, death, or last known follow-up, up to 2.5 years from end of RT (six weeks).

Population: Eligible Group I (wild-type p53) participants who started protocol treatment.

Disease is defined as any of the following:

Local, regional, or distant disease.

• Local disease: tumor recurrence or progression. Progression is defined as at 20% increase in the maximal dimension of the primary tumor taking as reference the smallest maximal dimension recorded since treatment started;
• Regional disease: Any nodal metastasis adjacent to the primary soft tissue sarcoma;
• Distant disease: Any tumor that develops distantly from the primary site of sarcoma;
• Amputation for treatment complications or recurrence/progression.
• Failure to continue to surgery.

Outcome measures

Measure	Cohort A n=3 Participants All participants who received at least one dose of 120 mg navtemadlin PO either 3 times/week (Dose Level 1), 4 times/week (Dose Level 2), or 5 times/week (Dose Level 3). Planned dosing was for six weeks; 50 Gy RT over 5 weeks starting week 2 day 1; surgery 5-8 weeks after RT completion.	Cohort B n=4 Participants All participants who received at least one dose of 120 mg navtemadlin PO either 3 times/week (Dose Level 1), 4 times/week (Dose Level 2), or 5 times/week (Dose Level 3). Planned dosing was for six weeks; 50 Gy RT over 5 weeks starting week 2 day 1; surgery 5-8 weeks after RT completion.	Cohort A: Dose Level 3 (5x/Week) n=9 Participants Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 1-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort A = Patients with extremity/body wall soft tissue sarcoma.wall soft tissue sarcoma.	Cohort B: Dose Level 1 (3x/Week) n=3 Participants Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.	Cohort B: Dose Level 2 (4x/Week) n=3 Participants Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.
Number of Participants With Disease or Death From Any Cause	1 Participants	2 Participants	4 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline to the date of death or last known follow-up, up to 2.5 years from end of RT (six weeks).

Population: Eligible Group I (wild-type p53) participants who started protocol treatment.

Death from any cause

Outcome measures

Measure	Cohort A n=3 Participants All participants who received at least one dose of 120 mg navtemadlin PO either 3 times/week (Dose Level 1), 4 times/week (Dose Level 2), or 5 times/week (Dose Level 3). Planned dosing was for six weeks; 50 Gy RT over 5 weeks starting week 2 day 1; surgery 5-8 weeks after RT completion.	Cohort B n=4 Participants All participants who received at least one dose of 120 mg navtemadlin PO either 3 times/week (Dose Level 1), 4 times/week (Dose Level 2), or 5 times/week (Dose Level 3). Planned dosing was for six weeks; 50 Gy RT over 5 weeks starting week 2 day 1; surgery 5-8 weeks after RT completion.	Cohort A: Dose Level 3 (5x/Week) n=9 Participants Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 1-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort A = Patients with extremity/body wall soft tissue sarcoma.wall soft tissue sarcoma.	Cohort B: Dose Level 1 (3x/Week) n=3 Participants Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.	Cohort B: Dose Level 2 (4x/Week) n=3 Participants Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.
Number of Participants Who Died	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 2.5 years

Will be tabulated and descriptive statistics and calculated for each dose level.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2.5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 2.5 years

Will be compared by paired t test.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 2.5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 2.5 years

Will be correlated with protein levels and assessed using Pearson's correlation.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 2.5 years

Outcome measures

Outcome data not reported

Adverse Events

Group I: Cohort A: Dose Level 1 (3x/Week)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Group I: Cohort A: Dose Level 2 (4x/Week)

Serious events: 4 serious events

Other events: 4 other events

Deaths: 1 deaths

Group I: Cohort A: Dose Level 3 (5x/Week)

Serious events: 5 serious events

Other events: 9 other events

Deaths: 1 deaths

Group I: Cohort B: Dose Level 1 (3x/Week)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Group I: Cohort B: Dose Level 2 (4x/Week)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Group II: Cohort A: Dose Level 2 (4x/Week)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Group II: Cohort A: Dose Level 3 (5x/Week)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Group II: Cohort B: Dose Level 1 (3x/Week)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Group II: Cohort B: Dose Level 2 (4x/Week)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group I: Cohort A: Dose Level 1 (3x/Week) n=3 participants at risk Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group I = Wild-type p53. Cohort A = Patients with extremity/body wall soft tissue sarcoma.	Group I: Cohort A: Dose Level 2 (4x/Week) n=4 participants at risk Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group I = Wild-type p53. Cohort A = Patients with extremity/body wall soft tissue sarcoma.	Group I: Cohort A: Dose Level 3 (5x/Week) n=9 participants at risk Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 1-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group I = Wild-type p53. Cohort A = Patients with extremity/body wall soft tissue sarcoma.	Group I: Cohort B: Dose Level 1 (3x/Week) n=3 participants at risk Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group I = Wild-type p53. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.	Group I: Cohort B: Dose Level 2 (4x/Week) n=3 participants at risk Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group I = Wild-type p53. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.	Group II: Cohort A: Dose Level 2 (4x/Week) n=2 participants at risk Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group II = Mutant/unknown p53. Cohort A = Patients with extremity/body wall soft tissue sarcoma.	Group II: Cohort A: Dose Level 3 (5x/Week) n=6 participants at risk Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group II = Mutant/unknown p53. Cohort A = Patients with extremity/body wall soft tissue sarcoma.	Group II: Cohort B: Dose Level 1 (3x/Week) n=2 participants at risk Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group II = Mutant/unknown p53. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.	Group II: Cohort B: Dose Level 2 (4x/Week) n=2 participants at risk Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group II = Mutant/unknown p53. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Nervous system disorders Syncope	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 2/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Renal and urinary disorders Urinary tract obstruction	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Vascular disorders Hypertension	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 3/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Gastrointestinal disorders Ileus	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Gastrointestinal disorders Mucositis oral	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Gastrointestinal disorders Nausea	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Gastrointestinal disorders Vomiting	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
General disorders Fatigue	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Immune system disorders Allergic reaction	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Infections and infestations Skin infection	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Infections and infestations Viremia	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Injury, poisoning and procedural complications Seroma	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Injury, poisoning and procedural complications Wound complication	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	22.2% 2/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Investigations Alanine aminotransferase increased	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Investigations Lipase increased	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	16.7% 1/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Investigations Lymphocyte count decreased	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	66.7% 2/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Investigations Neutrophil count decreased	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Investigations Serum amylase increased	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 2/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).

Other adverse events

Measure	Group I: Cohort A: Dose Level 1 (3x/Week) n=3 participants at risk Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group I = Wild-type p53. Cohort A = Patients with extremity/body wall soft tissue sarcoma.	Group I: Cohort A: Dose Level 2 (4x/Week) n=4 participants at risk Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group I = Wild-type p53. Cohort A = Patients with extremity/body wall soft tissue sarcoma.	Group I: Cohort A: Dose Level 3 (5x/Week) n=9 participants at risk Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 1-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group I = Wild-type p53. Cohort A = Patients with extremity/body wall soft tissue sarcoma.	Group I: Cohort B: Dose Level 1 (3x/Week) n=3 participants at risk Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group I = Wild-type p53. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.	Group I: Cohort B: Dose Level 2 (4x/Week) n=3 participants at risk Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group I = Wild-type p53. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.	Group II: Cohort A: Dose Level 2 (4x/Week) n=2 participants at risk Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group II = Mutant/unknown p53. Cohort A = Patients with extremity/body wall soft tissue sarcoma.	Group II: Cohort A: Dose Level 3 (5x/Week) n=6 participants at risk Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-5 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group II = Mutant/unknown p53. Cohort A = Patients with extremity/body wall soft tissue sarcoma.	Group II: Cohort B: Dose Level 1 (3x/Week) n=2 participants at risk Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group II = Mutant/unknown p53. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.	Group II: Cohort B: Dose Level 2 (4x/Week) n=2 participants at risk Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 2-4 of week 1 in the absence of disease progression or unacceptable toxicity. Step 2: Starting with week 2, patients undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion. Group II = Mutant/unknown p53. Cohort B = Patients with abdomen/pelvis/retroperitoneum soft tissue sarcoma.
Blood and lymphatic system disorders Anemia	100.0% 3/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 3/9 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 2/6 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).
Cardiac disorders Cardiac disorders - Other	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Ear and labyrinth disorders Vertigo	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	16.7% 1/6 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Gastrointestinal disorders Belching	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Gastrointestinal disorders Bloating	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	22.2% 2/9 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Gastrointestinal disorders Constipation	66.7% 2/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	66.7% 6/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Gastrointestinal disorders Diarrhea	100.0% 3/3 • Baseline to 2.5 years from end of RT (six weeks).	75.0% 3/4 • Baseline to 2.5 years from end of RT (six weeks).	88.9% 8/9 • Baseline to 2.5 years from end of RT (six weeks).	100.0% 3/3 • Baseline to 2.5 years from end of RT (six weeks).	100.0% 3/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	66.7% 4/6 • Baseline to 2.5 years from end of RT (six weeks).	100.0% 2/2 • Baseline to 2.5 years from end of RT (six weeks).	100.0% 2/2 • Baseline to 2.5 years from end of RT (six weeks).
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	22.2% 2/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Gastrointestinal disorders Flatulence	100.0% 3/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Gastrointestinal disorders Gastrointestinal disorders - Other	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Gastrointestinal disorders Mucositis oral	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Gastrointestinal disorders Nausea	66.7% 2/3 • Baseline to 2.5 years from end of RT (six weeks).	100.0% 4/4 • Baseline to 2.5 years from end of RT (six weeks).	88.9% 8/9 • Baseline to 2.5 years from end of RT (six weeks).	100.0% 3/3 • Baseline to 2.5 years from end of RT (six weeks).	100.0% 3/3 • Baseline to 2.5 years from end of RT (six weeks).	100.0% 2/2 • Baseline to 2.5 years from end of RT (six weeks).	66.7% 4/6 • Baseline to 2.5 years from end of RT (six weeks).	100.0% 2/2 • Baseline to 2.5 years from end of RT (six weeks).	100.0% 2/2 • Baseline to 2.5 years from end of RT (six weeks).
Gastrointestinal disorders Oral dysesthesia	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Gastrointestinal disorders Vomiting	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 2/4 • Baseline to 2.5 years from end of RT (six weeks).	44.4% 4/9 • Baseline to 2.5 years from end of RT (six weeks).	100.0% 3/3 • Baseline to 2.5 years from end of RT (six weeks).	100.0% 3/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 2/6 • Baseline to 2.5 years from end of RT (six weeks).	100.0% 2/2 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).
General disorders Chills	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 2/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
General disorders Edema limbs	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	55.6% 5/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	16.7% 1/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
General disorders Edema trunk	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
General disorders Fatigue	100.0% 3/3 • Baseline to 2.5 years from end of RT (six weeks).	75.0% 3/4 • Baseline to 2.5 years from end of RT (six weeks).	88.9% 8/9 • Baseline to 2.5 years from end of RT (six weeks).	66.7% 2/3 • Baseline to 2.5 years from end of RT (six weeks).	100.0% 3/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	66.7% 4/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
General disorders Fever	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 2/6 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
General disorders General disorders and administration site conditions - Other	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
General disorders Localized edema	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 2/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
General disorders Non-cardiac chest pain	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
General disorders Pain	66.7% 2/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	22.2% 2/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	16.7% 1/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	16.7% 1/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Infections and infestations Enterocolitis infectious	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).
Infections and infestations Infections and infestations - Other	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Infections and infestations Papulopustular rash	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Infections and infestations Sepsis	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Infections and infestations Thrush	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Infections and infestations Viremia	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Injury, poisoning and procedural complications Burn	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Injury, poisoning and procedural complications Dermatitis radiation	66.7% 2/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	66.7% 6/9 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 2/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Injury, poisoning and procedural complications Radiation recall reaction (dermatologic)	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Injury, poisoning and procedural complications Seroma	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Injury, poisoning and procedural complications Wound complication	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Investigations Activated partial thromboplastin time prolonged	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Investigations Alanine aminotransferase increased	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Investigations Alkaline phosphatase increased	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Investigations Creatinine increased	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).
Investigations INR increased	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).
Investigations Investigations - Other	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 2/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Investigations Lipase increased	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).
Investigations Lymphocyte count decreased	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	66.7% 2/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	16.7% 1/6 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Investigations Neutrophil count decreased	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Investigations Serum amylase increased	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	16.7% 1/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Investigations Weight loss	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	100.0% 4/4 • Baseline to 2.5 years from end of RT (six weeks).	77.8% 7/9 • Baseline to 2.5 years from end of RT (six weeks).	66.7% 2/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	16.7% 1/6 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).
Metabolism and nutrition disorders Hypoalbuminemia	66.7% 2/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Metabolism and nutrition disorders Hyponatremia	66.7% 2/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Musculoskeletal and connective tissue disorders Joint range of motion decreased	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Musculoskeletal and connective tissue disorders Muscle cramp	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	22.2% 2/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	44.4% 4/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 2/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Musculoskeletal and connective tissue disorders Superficial soft tissue fibrosis	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	22.2% 2/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Nervous system disorders Dizziness	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 2/4 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 3/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Nervous system disorders Dysgeusia	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	66.7% 2/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Nervous system disorders Headache	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Nervous system disorders Memory impairment	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Nervous system disorders Muscle weakness left-sided	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Nervous system disorders Nervous system disorders - Other	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Nervous system disorders Paresthesia	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	22.2% 2/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Nervous system disorders Peripheral sensory neuropathy	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Nervous system disorders Syncope	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Nervous system disorders Tremor	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Psychiatric disorders Anxiety	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 3/9 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Psychiatric disorders Confusion	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Psychiatric disorders Depression	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Psychiatric disorders Insomnia	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	22.2% 2/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Renal and urinary disorders Renal and urinary disorders - Other	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Renal and urinary disorders Urinary frequency	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	22.2% 2/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Renal and urinary disorders Urinary retention	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Renal and urinary disorders Urinary urgency	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 2/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 1/2 • Baseline to 2.5 years from end of RT (six weeks).	16.7% 1/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Respiratory, thoracic and mediastinal disorders Voice alteration	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 2/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	25.0% 1/4 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 3/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Skin and subcutaneous tissue disorders Skin atrophy	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	16.7% 1/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Skin and subcutaneous tissue disorders Skin hyperpigmentation	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	50.0% 2/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Skin and subcutaneous tissue disorders Skin induration	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	16.7% 1/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Vascular disorders Hypertension	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	33.3% 1/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).
Vascular disorders Thromboembolic event	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/4 • Baseline to 2.5 years from end of RT (six weeks).	11.1% 1/9 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/3 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/6 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).	0.00% 0/2 • Baseline to 2.5 years from end of RT (six weeks).

Additional Information

Wendy Seiferheld

NRG Oncology

Phone: 215-574-3208

Email: seiferheldw@nrgoncology.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60