Trial Outcomes & Findings for A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid Tumors (NCT NCT04029688)

NCT ID: NCT04029688

Last Updated: 2024-12-20

Results Overview

An AE is any untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were graded as per NCI CTCAE v5.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to adverse event.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 38 participants
• Primary outcome timeframe: From screening up to 30 days after study treatment discontinuation (approximately 7 months)
• Results posted on: 2024-12-20

Participant Flow

Participants with relapsed/refractory solid tumors took part in the study across 12 investigative sites in 6 countries (United States, Spain, United Kingdom, France, Canada, and Netherlands) from January 27, 2020 to May 6, 2024.

Study was divided into 3 parts. Part 1a: Single agent idasanutlin dose escalation in pediatric participants with solid tumors. Part 1b: Combination safety run-in in participants with neuroblastoma/acute leukemia. Part 2: Early efficacy in participants with neuroblastoma/acute leukemia. Part 3: Expansion cohorts in participants with neuroblastoma/acute leukemia. Leukemia cohorts in Part 1b & all cohorts in Part 2 & Part 3 were never initiated due to early termination of the study by the sponsor.

Participant milestones

Measure	Part 1a: Idasanutlin 2 Milligrams/Kilograms (mg/kg) Participants with solid tumors received idasanutlin 2 mg/kg orally once daily (QD) on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8 mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 milligrams per square meter (mg/m\^2) and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6 mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 milligrams (mg) adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Overall Study STARTED	8	3	6	3	6	3	3	6
Overall Study COMPLETED	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	8	3	6	3	6	3	3	6

Reasons for withdrawal

Measure	Part 1a: Idasanutlin 2 Milligrams/Kilograms (mg/kg) Participants with solid tumors received idasanutlin 2 mg/kg orally once daily (QD) on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8 mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 milligrams per square meter (mg/m\^2) and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6 mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 milligrams (mg) adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Overall Study Death	8	3	6	2	5	0	2	3
Overall Study Study Terminated by Sponsor	0	0	0	0	1	3	1	3
Overall Study Withdrawal by Subject	0	0	0	1	0	0	0	0

Baseline Characteristics

A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid Tumors

Baseline characteristics by cohort

Measure	Part 1a: Idasanutlin 2 mg/kg n=8 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8 mg/kg) +Chemotherapy n=3 Participants Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6 mg/kg) +Chemotherapy n=3 Participants Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax n=6 Participants Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Total n=38 Participants Total of all reporting groups
Age, Continuous	7.6 years STANDARD_DEVIATION 5.0 • n=5 Participants	11.3 years STANDARD_DEVIATION 3.2 • n=7 Participants	7.3 years STANDARD_DEVIATION 3.9 • n=5 Participants	15.0 years STANDARD_DEVIATION 1.7 • n=4 Participants	11.5 years STANDARD_DEVIATION 5.0 • n=21 Participants	15.0 years STANDARD_DEVIATION 11.4 • n=8 Participants	5.3 years STANDARD_DEVIATION 1.2 • n=8 Participants	8.0 years STANDARD_DEVIATION 3.8 • n=24 Participants	9.5 years STANDARD_DEVIATION 5.4 • n=42 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	16 Participants n=42 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	4 Participants n=24 Participants	22 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	6 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	2 Participants n=8 Participants	2 Participants n=24 Participants	20 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	3 Participants n=24 Participants	12 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants	21 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants	14 Participants n=42 Participants

PRIMARY outcome

Timeframe: From screening up to 30 days after study treatment discontinuation (approximately 7 months)

Population: Safety evaluable (SE) population included all participants who received any amount of the study treatment, whether prematurely withdrawn from the study or not.

An AE is any untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were graded as per NCI CTCAE v5.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to adverse event.

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg n=8 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy n=3 Participants Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy n=3 Participants Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax n=6 Participants Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Part 1a and 1b: Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0) AEs, Any Grade	8 Participants	3 Participants	6 Participants	3 Participants	6 Participants	3 Participants	3 Participants	6 Participants
Part 1a and 1b: Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0) AEs, Grade 1	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1a and 1b: Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0) AEs, Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Part 1a and 1b: Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0) AEs, Grade 3	2 Participants	1 Participants	3 Participants	2 Participants	1 Participants	0 Participants	0 Participants	3 Participants
Part 1a and 1b: Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0) AEs, Grade 4	5 Participants	2 Participants	3 Participants	1 Participants	5 Participants	3 Participants	3 Participants	1 Participants
Part 1a and 1b: Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0) AEs, Grade 5	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Cycle 1 (one cycle is 28 days)

Population: DLT-evaluable population included all participants enrolled in Part 1 who either completed at least 80% of the prescribed dose of idasanutlin and the DLT observation window in Cycle 1 OR have experienced a DLT in Cycle 1 of the dose-escalation phase.

DLTs were assessed for single-agent idasanutlin and idasanutlin in combination with chemotherapy or venetoclax. A DLT was defined as any AE that occurred during the DLT assessment window and was assessed by the investigator as related or possibly related to idasanutlin. An AE is an untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. Following events were considered to be DLTs: any treatment-related death; elevation of serum hepatic transaminase; severe liver injury, in the absence of cholestasis or other causes of hyperbilirubinemia; any non-hematologic toxicity Grade ≥3; nausea, vomiting, and/or diarrhea if Grade 3 severity lasts > than 24 hours after initiation of supportive care measures or if Grade 4 or higher; hematologic toxicity; any related event that results in a dose delay beyond Day 42.

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg n=8 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy n=3 Participants Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy n=3 Participants Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax n=6 Participants Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Parts 1a and 1b: Number of Participants With Dose-Limiting Toxicities (DLTs)	0 Participants	0 Participants	1 Participants	0 Participants	4 Participants	1 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: From screening (maximum 28 days) up to Cycle 6 (cycle length=28 days)

Population: Participants in the SE population who had TP53 WT tumor as assessed by central testing were analyzed for this outcome measure. SE Population included all participants who received any amount of the study treatment, whether prematurely withdrawn from the study or not. Percentages have been rounded off to the nearest decimal point.

ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) at any time during study treatment, on 2 consecutive occasions ≥ 4 weeks apart, as determined by the investigator per INRC. Primary tumor: CR = <10 millimeters (mm) residual soft tissue at primary site and complete resolution of meta-iodobenzylguanidine (MIBG) or fluorodeoxyglucose-positron emission tomography (FDG-PET) uptake at primary site. PR = ≥ 30% decrease in longest diameter of primary site and MIBG or FDG-PET uptake at primary site stable, improved, or resolved. Soft tissue & bone metastases: CR = resolution of all disease sites; PR = ≥30% decrease in sum of non-primary target lesions, with no new lesions or ≥50% reduction in MIBG score or in number of FDG-PET-avid bone lesions; Bone marrow: CR = no tumor infiltration on reassessment.

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg n=2 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=4 Participants Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Part 1b: Objective Response Rate (ORR) in Participants With TP53 Wild-Type (WT) Neuroblastoma Assessed According to International Neuroblastoma Response Criteria (INRC)	0 percentage of participants Interval 0.0 to 84.19	33.3 percentage of participants Interval 0.84 to 90.57	0 percentage of participants Interval 0.0 to 60.24	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to approximately 29 months

Population: The study was terminated before initiation of Parts 2 and 3 as per sponsor's decision. Hence no data were collected, and this outcome measure was not assessed or analyzed.

ORR was defined as the percentage of participants with CR or PR at any time during study treatment, on 2 consecutive occasions ≥ 4 weeks apart, as determined by the investigator per INRC. Primary tumor: CR = <10 mm residual soft tissue at primary site and complete resolution of MIBG or FDG-PET uptake at primary site. PR = ≥ 30% decrease in longest diameter of primary site and MIBG or FDG-PET uptake at primary site stable, improved, or resolved. Soft tissue & bone metastases: CR = resolution of all disease sites; PR = ≥30% decrease in sum of non-primary target lesions, with no new lesions or ≥50% reduction in MIBG score or in number of FDG-PET-avid bone lesions; Bone marrow: CR = no tumor infiltration on reassessment.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to Cycle 2 (cycle length=28 days) (approximately 8 weeks)

Population: The study was terminated before initiation of Parts 2 and 3 as per sponsor's decision. Hence no data were collected, and this outcome measure was not assessed or analyzed.

CRR was defined as the percentage of participants with morphologic complete remission (CR), complete remission with incomplete blood count recovery (CRi), or complete remission with incomplete platelet count recovery (CRp) within 2 cycles of study treatment. CR=Bone marrow blasts <5% (AML) and no evidence of circulating blasts, must be <1% (ALL); absence of blasts with Auer rods (AML); absence of extramedullary disease; absolute neutrophil count (ANC) >1.0*10^9/liter (L) [1000/microliter (µL)]; platelet count > 100*10^9/L (100,000/µL); independence of transfusions for a minimum of 1 week (AML and ALL). CRi= All CR criteria except for ANC <1.0*10^9/L[1000/µL] or insufficient recovery of platelet count <100* 10^9/L [100,000/µL] (AML and ALL). CRp=All CR criteria except for ANC >1.0*10^9/L[1000/µL]) or but with insufficient recovery of platelet (<100* 10^9/L [100,000/µL]) (ALL).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to Cycle 2 (cycle length=28 days) (approximately 8 weeks)

Population: The study was terminated before initiation of Parts 2 and 3 as per sponsor's decision. Hence no data were collected, and this outcome measure was not assessed or analyzed.

MRD - negative rate was defined as percentage of participants with ALL who have an MRD value < 0.01%, as measured by next-generation sequencing (NGS), within 2 cycles of study treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From screening (maximum 28 days) up to Cycle 5 (cycle length=28 days)

Population: SE population included all participants who received any amount of the study treatment, whether prematurely withdrawn from the study or not. Percentages have been rounded off to the nearest decimal point.

CBR was defined as the percentage of participants achieving confirmed CR, PR, or stable disease (SD) on 2 consecutive occasions ≥4 weeks apart during the total study period. Per RECIST, CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference smallest sum on study. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference smallest sum on study (nadir), including baseline. Participants who had neuroblastoma were assessed by INRC. CR and PR per INRC were defined as outlined in the description for Part 1b: ORR outcome measure (OM).

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg n=8 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Part 1a: Clinical Benefit Rate (CBR) in Participants With Solid Tumors From SE Population Assessed According to Response Evaluation Criteria Version 1.1 (RECIST v1.1) or INRC	12.5 percentage of participants Interval 0.32 to 52.65	33.3 percentage of participants Interval 0.84 to 90.57	0 percentage of participants Interval 0.0 to 45.93	66.7 percentage of participants Interval 9.43 to 99.16	0 percentage of participants Interval 0.0 to 45.93	—	—	—

SECONDARY outcome

Timeframe: From screening (maximum 28 days) up to Cycle 6 (cycle length=28 days)

Population: SE population included all participants who received any amount of the study treatment, whether prematurely withdrawn from the study or not. Percentages have been rounded off to the nearest decimal point.

CBR=percentage of participants with CR, PR, or SD on 2 consecutive occasions ≥ 4 weeks apart per INRC. Primary tumor: CR=residual soft tissue at primary site is <10 mm, with complete resolution of MIBG/FDG-PET uptake; PR= ≥30% decrease in longest diameter (LD) of primary site, with stable/improved MIBG/FDG-PET uptake; SD=Insufficient shrinkage for PR/increase for PD. PD= >20% increase in LD from smallest sum & minimum 5 mm increase in LD. Soft tissue & bone metastases: CR=resolution of all disease sites; PR= ≥30% decrease in sum of non-primary target lesions, with no new lesions or ≥50% reduction in MIBG score or in number of FDG-PET-avid bone lesions; PD=new soft tissue lesions per CT/MRI or MIBG/FDG-PET avid bone site; SD=no sufficient change in non-primary lesions. Bone marrow: CR=no tumor infiltration on reassessment; PD=new tumor infiltration >5% or infiltration increased >2-fold with >20% tumor infiltration; SD=persistent infiltration at >5% without meeting other criteria.

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Part 1b: CBR in Participants With Neuroblastoma From SE Population Assessed According to INRC	33.3 percentage of participants Interval 0.84 to 90.57	33.3 percentage of participants Interval 0.84 to 90.57	0 percentage of participants Interval 0.0 to 45.93	—	—	—	—	—

SECONDARY outcome

Timeframe: From screening (maximum 28 days) up to Cycle 6 (cycle length=28 days)

Population: Participants in the SE population who had TP53 WT tumor as assessed by central testing were analyzed for this outcome measure. SE Population included all participants who received any amount of the study treatment, whether prematurely withdrawn from the study or not. Percentages have been rounded off to the nearest decimal point.

CBR=percentage of participants with CR, PR, or SD on 2 consecutive occasions ≥ 4 weeks apart per INRC. Primary tumor: CR=residual soft tissue at primary site is <10 mm, with complete resolution of MIBG/FDG-PET uptake; PR= ≥30% decrease in longest diameter (LD) of primary site, with stable/improved MIBG/FDG-PET uptake; SD=Insufficient shrinkage for PR or increase for PD. PD= >20% increase in LD from smallest sum & minimum 5 mm increase in LD. Soft tissue & bone metastases: CR=resolution of all disease sites; PR= ≥30% decrease in sum of non-primary target lesions, with no new lesions or ≥50% reduction in MIBG score or in number of FDG-PET-avid bone lesions; PD=new soft tissue lesions per CT/MRI or MIBG/FDG-PET avid bone site; SD=no sufficient change in non-primary lesions. Bone marrow: CR=no tumor infiltration on reassessment; PD=new tumor infiltration >5% or infiltration increased >2-fold with >20% tumor infiltration; SD=persistent infiltration at >5% without meeting other criteria.

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg n=2 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=4 Participants Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Part 1b: CBR in Participants With TP53 WT Neuroblastoma Assessed According to INRC	50.0 percentage of participants Interval 1.26 to 98.74	33.3 percentage of participants Interval 0.84 to 90.57	0 percentage of participants Interval 0.0 to 60.24	—	—	—	—	—

SECONDARY outcome

Timeframe: From screening (maximum 28 days) up to Cycle 5 (cycle length=28 days)

Population: SE population included all participants who received any amount of the study treatment, whether prematurely withdrawn from the study or not. DOR was only evaluated in participants who achieved an objective response (CR or PR).

DOR was defined as the time from the first tumor assessment that supports a participant's objective response (CR or PR) to the time of PD or death from any cause (whichever occurs first), as determined by the investigator using RECIST v1.1 or INRC. Per PRECIST, CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference smallest sum on study (nadir), including baseline. Participants who had neuroblastoma were assessed by INRC. CR/PR/PD were defined per INRC as outlined in the description for the Part 1b: CBR OM.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From screening (maximum 28 days) up to Cycle 6 (cycle length=28 days)

Population: SE population included all participants who received any amount of the study treatment, whether prematurely withdrawn from the study or not. DOR was only evaluated in participants who achieved an objective response (CR or PR).

DOR=time from the first tumor assessment that supports a participant's objective response (CR or PR) to the time of PD or death from any cause (whichever occurs first), as determined by the investigator using INRC for participants with neuroblastoma. Primary tumor: CR=residual soft tissue at primary site is <10 mm, with complete resolution of MIBG/FDG-PET uptake; PR= ≥30% decrease in LD of primary site and MIBG or FDG-PET uptake at primary site stable, improved, or resolved; PD= >20% increase in LD from smallest sum & minimum 5 mm increase in LD. Soft tissue & bone metastases: CR = resolution of all disease sites; PR = ≥30% decrease in sum of non-primary target lesions, with no new lesions or ≥50% reduction in MIBG score or in number of FDG-PET-avid bone lesions; PD=new soft tissue lesions per CT/MRI or MIBG/FDG-PET avid bone site. Bone marrow: CR=no tumor infiltration on reassessment; PD=new tumor infiltration >5% or infiltration increased >2-fold with >20% tumor infiltration.

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=1 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Part 1b: DOR in Participants With Neuroblastoma From SE Population Assessed According to INRC	—	4.5 months Since only one participant showed response upper and lower limit of 95% CI were not evaluable.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From screening (maximum 28 days) up to Cycle 6 (cycle length=28 days)

Population: Participants in the SE population who had TP53 WT tumor as assessed by central testing were analyzed for this outcome measure. SE Population included all participants who received any amount of the study treatment, whether prematurely withdrawn from the study or not. DOR was only evaluated in participants who achieved an objective response (CR or PR).

DOR=time from the first tumor assessment that supports a participant's objective response (CR or PR) to the time of PD or death from any cause (whichever occurs first), as determined by the investigator using INRC for participants with neuroblastoma. Primary tumor: CR=residual soft tissue at primary site is <10 mm, with complete resolution of MIBG/FDG-PET uptake; PR= ≥30% decrease in LD of primary site and MIBG or FDG-PET uptake at primary site stable, improved, or resolved; PD= >20% increase in LD from smallest sum & minimum 5 mm increase in LD. Soft tissue & bone metastases: CR = resolution of all disease sites; PR = ≥30% decrease in sum of non-primary target lesions, with no new lesions or ≥50% reduction in MIBG score or in number of FDG-PET-avid bone lesions; PD=new soft tissue lesions per CT/MRI or MIBG/FDG-PET avid bone site. Bone marrow: CR=no tumor infiltration on reassessment; PD=new tumor infiltration >5% or infiltration increased >2-fold with >20% tumor infiltration.

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=1 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Part 1b: DOR in in Participants With TP53 WT Neuroblastoma Assessed According to INRC	—	4.5 months Since only one participant showed response upper and lower limit of 95% CI were not evaluable.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From screening (maximum 28 days) up to Cycle 5 (cycle length=28 days)

Population: SE population included all participants who received any amount of the study treatment, whether prematurely withdrawn from the study or not.

PFS was defined as the time from initiation of study drug to the first documented occurrence of PD or death from any cause (whichever occurs first), as determined by the investigator using RECIST or INRC. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference smallest sum on study (nadir), including baseline. Participants who had neuroblastoma were assessed by INRC. PD per INRC: Primary tumor = >20% increase in LD from smallest sum & minimum 5 mm increase in LD; Soft tissue & bone metastases = new soft tissue lesions per CT/MRI or MIBG/FDG-PET avid bone site; Bone marrow = new tumor infiltration >5% or infiltration increased >2-fold with >20% tumor infiltration.

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg n=8 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Part 1a: Progression Free Survival (PFS) in Participants With Solid Tumors From SE Population Assessed According to RECIST v1.1 or INRC	0.8 months Interval 0.7 to 1.3	0.9 months Interval 0.9 to The upper limit of the 95% CI was not estimable because there was an insufficient number of events.	0.8 months Interval 0.8 to 0.9	3.5 months Interval 2.8 to The upper limit of the 95% CI was not estimable because there was an insufficient number of events.	1.9 months Interval 0.8 to The upper limit of the 95% CI was not estimable because there was an insufficient number of events.	—	—	—

SECONDARY outcome

Timeframe: From screening (maximum 28 days) up to Cycle 6 (cycle length=28 days)

Population: SE population included all participants who received any amount of the study treatment, whether prematurely withdrawn from the study or not.

PFS was defined as the time from initiation of study drug to the first documented occurrence of PD or death from any cause (whichever occurs first), as determined by the investigator using INRC for participants with neuroblastoma. Primary tumor: PD= >20% increase in LD from smallest sum & minimum 5 mm increase in LD. Soft tissue & bone metastases: PD=new soft tissue lesions per CT/MRI or MIBG/FDG-PET avid bone site. Bone marrow: PD=new tumor infiltration >5% or infiltration increased >2-fold with >20% tumor infiltration.

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Part 1b: PFS in Participants With Neuroblastoma From SE Population Assessed According to INRC	1.9 months Interval 1.8 to The upper limit of the 95% CI was not estimable because there was an insufficient number of events.	1.8 months Interval 1.6 to The upper limit of the 95% CI was not estimable because there was an insufficient number of events.	1.7 months Interval 1.0 to The upper limit of the 95% CI was not estimable because there was an insufficient number of events.	—	—	—	—	—

SECONDARY outcome

Timeframe: From screening (maximum 28 days) up to Cycle 6 (cycle length=28 days)

Population: Participants in the SE population who had TP53 WT tumor as assessed by central testing were analyzed for this outcome measure. SE Population included all participants who received any amount of the study treatment, whether prematurely withdrawn from the study or not.

PFS was defined as the time from initiation of study drug to the first documented occurrence of PD or death from any cause (whichever occurs first), as determined by the investigator using INRC for participants with neuroblastoma. Primary tumor: PD= >20% increase in LD from smallest sum & minimum 5 mm increase in LD. Soft tissue & bone metastases: PD=new soft tissue lesions per CT/MRI or MIBG/FDG-PET avid bone site. Bone marrow: PD=new tumor infiltration >5% or infiltration increased >2-fold with >20% tumor infiltration.

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg n=2 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=4 Participants Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Part 1b: PFS in Participants With TP53 WT Neuroblastoma Assessed According to INRC	NA months Interval 1.8 to The Median \& upper limit of the 95% CI was not estimable because there was an insufficient number of events.	1.8 months Interval 1.6 to The upper limit of the 95% CI was not estimable because there was an insufficient number of events.	1.7 months Interval 1.5 to The upper limit of the 95% CI was not estimable because there was an insufficient number of events.	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: SE population included all participants who received any amount of the study treatment, whether prematurely withdrawn from the study or not.

OS was defined as the time from initiation of the study drug to death from any cause. Estimates for median OS were computed using Kaplan-Meier methodology

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg n=8 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy n=3 Participants Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy n=3 Participants Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax n=6 Participants Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Parts 1a and 1b: Overall Survival (OS) in SE Population	5.6 months Interval 2.1 to 20.8	12.5 months Interval 1.1 to Because of the small sample size, there is not enough information to construct a reliable upper confidence limit of the 95% CI for median survival using the applied Kaplan-Meier methodology.	3.6 months Interval 2.3 to 9.8	16.4 months Interval 7.2 to Because of the small sample size, there is not enough information to construct a reliable upper confidence limit of the 95% CI for median survival using the applied Kaplan-Meier methodology.	5.4 months Interval 3.4 to The upper limit of the 95% CI was not estimable because there was an insufficient number of events.	NA months The median and upper and lower limit of the 95% CI was not estimable because there was an insufficient number of events.	3.2 months Interval 1.6 to Because of the small sample size, there is not enough information to construct a reliable upper confidence limit of the 95% CI for median survival using the applied Kaplan-Meier methodology.	NA months Interval 2.9 to Because of the small sample size, there is not enough information to construct a reliable upper confidence limit of the 95% CI for median survival using the applied Kaplan-Meier methodology.

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: Participants in the SE population who had TP53 WT tumor as assessed by central testing were analyzed for this outcome measure. SE Population included all participants who received any amount of the study treatment, whether prematurely withdrawn from the study or not.

OS was defined as the time from initiation of the study drug to death from any cause. Estimates for median OS were computed using Kaplan-Meier methodology

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg n=2 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=4 Participants Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Part 1b: OS in Participants With TP53 WT Neuroblastoma	NA months The median and upper and lower limit of the 95% CI was not estimable because there was an insufficient number of events.	3.2 months Interval 1.6 to The upper limit of the 95% CI was not estimable because there was an insufficient number of events.	NA months Interval 1.5 to The upper limit of the 95% CI was not estimable because there was an insufficient number of events.	—	—	—	—	—

SECONDARY outcome

Timeframe: From screening (maximum 28 days) up to Cycle 5 (cycle length=28 days)

Population: SE population included all participants who received any amount of the study treatment, whether prematurely withdrawn from the study or not.

ORR was defined as the percentage of participants with CR or PR at any time during study treatment, on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to RECIST v1.1 or INRC. Per RECIST, CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. Participants who had neuroblastoma were assessed by INRC. Per INRC, CR= <10 mm residual soft tissue at primary site and complete resolution of MIBG or FDG-PET uptake at primary site. PR= ≥ 30% decrease in longest diameter of primary site and MIBG or FDG-PET uptake at primary site stable, improved, or resolved. Soft tissue & bone metastases: CR= resolution of all disease sites; PR= ≥30% decrease in sum of non-primary target lesions, with no new lesions or ≥50% reduction in MIBG score or in number of FDG-PET-avid bone lesions; Bone marrow: CR= no tumor infiltration on reassessment.

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg n=8 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Part 1a: ORR Irrespective of TP53 Status in Participants With Solid Tumor From SE Population According to RECIST v1.1 or INRC	0 percentage of participants Interval 0.0 to 36.94	0 percentage of participants Interval 0.0 to 70.76	0 percentage of participants Interval 0.0 to 45.93	0 percentage of participants Interval 0.0 to 70.76	0 percentage of participants Interval 0.0 to 45.93	—	—	—

SECONDARY outcome

Timeframe: From screening (maximum 28 days) up to Cycle 6 (cycle length=28 days)

Population: SE population included all participants who received any amount of the study treatment, whether prematurely withdrawn from the study or not.

ORR was defined as the percentage of participants with CR or PR at any time during study treatment, on 2 consecutive occasions ≥ 4 weeks apart, as determined by the investigator per INRC. Primary tumor: CR= <10 mm residual soft tissue at primary site and complete resolution of MIBG or FDG-PET uptake at primary site. PR= ≥ 30% decrease in longest diameter of primary site and MIBG or FDG-PET uptake at primary site stable, improved, or resolved. Soft tissue & bone metastases: CR= resolution of all disease sites; PR= ≥30% decrease in sum of non-primary target lesions, with no new lesions or ≥50% reduction in MIBG score or in number of FDG-PET-avid bone lesions; Bone marrow: CR= no tumor infiltration on reassessment. Percentages have been rounded off to nearest decimal point.

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Part 1b: ORR Irrespective of TP53 Status in Participants With Neuroblastoma From SE Population According to INRC	0 percentage of participants Interval 0.0 to 70.76	33.3 percentage of participants Interval 0.84 to 90.57	0 percentage of participants Interval 0.0 to 45.93	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 1 and 5 of Cycle 1 (cycle length = 28 days)

Population: Pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of study treatment and who have data from at least one post dose sample. One participant assigned to the 6.4 mg/kg dose level received a dose of 3.8 mg/kg due to the maximum absolute dose cap of 300 mg/day in protocol v3 and earlier. Hence this participant has been reported in a separate arm for PK analysis.

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg n=8 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=1 Participants Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg n=2 Participants Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy n=6 Participants Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Part 1a: Maximum Plasma Concentration (Cmax) of Idasanutlin as a Monotherapy Cycle 1 Day 1	1429 ng/mL(nanograms/millilitres) Geometric Coefficient of Variation 36	2110 ng/mL(nanograms/millilitres) Geometric Coefficient of Variation 27	1560 ng/mL(nanograms/millilitres) Geometric Coefficient of Variation NA Since only 1 participant was analyzed Geometric Coefficient of Variation was not estimable.	3174 ng/mL(nanograms/millilitres) Geometric Coefficient of Variation 25	4474 ng/mL(nanograms/millilitres) Geometric Coefficient of Variation 90	5102 ng/mL(nanograms/millilitres) Geometric Coefficient of Variation 67	—	—
Part 1a: Maximum Plasma Concentration (Cmax) of Idasanutlin as a Monotherapy Cycle 1 Day 5	2548 ng/mL(nanograms/millilitres) Geometric Coefficient of Variation 21	2784 ng/mL(nanograms/millilitres) Geometric Coefficient of Variation 27	2940 ng/mL(nanograms/millilitres) Geometric Coefficient of Variation NA Since only 1 participant was analyzed Geometric Coefficient of Variation was not estimable.	4892 ng/mL(nanograms/millilitres) Geometric Coefficient of Variation 53	7748 ng/mL(nanograms/millilitres) Geometric Coefficient of Variation 81	6298 ng/mL(nanograms/millilitres) Geometric Coefficient of Variation 67	—	—

SECONDARY outcome

Timeframe: Days 1 and 5 of Cycle 1 (cycle length = 28 days)

Population: PK-evaluable population included all participants who received at least one dose of study treatment and who have data from at least one post dose sample.

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Part 1b: Cmax of Idasanutlin in Combination With Chemotherapy or Venetoclax Cycle 1 Day 1	2834 ng/mL Geometric Coefficient of Variation 31	1540 ng/mL Geometric Coefficient of Variation 11	2131 ng/mL Geometric Coefficient of Variation 43	—	—	—	—	—
Part 1b: Cmax of Idasanutlin in Combination With Chemotherapy or Venetoclax Cycle 1 Day 5	2393 ng/mL Geometric Coefficient of Variation 32	2110 ng/mL Geometric Coefficient of Variation 72	2272 ng/mL Geometric Coefficient of Variation 32	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 1 and 5 of Cycle 1 (cycle length = 28 days)

Population: PK-evaluable population included all participants who received at least one dose of study treatment and who have data from at least one post dose sample. One participant assigned to the 6.4 mg/kg dose level received a dose of 3.8 mg/kg due to the maximum absolute dose cap of 300 mg/day in protocol v3 and earlier. Hence this participant has been reported in a separate arm for PK analysis.

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg n=8 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=1 Participants Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg n=2 Participants Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy n=6 Participants Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Part 1a: Cmax of Idasanutilin Metabolite M4 Following Idasanutilin as a Monotherapy Cycle 1 Day 1	129 ng/mL Geometric Coefficient of Variation 63	184 ng/mL Geometric Coefficient of Variation 39	72 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed Geometric Coefficient of Variation was not estimable.	340 ng/mL Geometric Coefficient of Variation 60	542 ng/mL Geometric Coefficient of Variation 153	575 ng/mL Geometric Coefficient of Variation 148	—	—
Part 1a: Cmax of Idasanutilin Metabolite M4 Following Idasanutilin as a Monotherapy Cycle 1 Day 5	436 ng/mL Geometric Coefficient of Variation 73	419 ng/mL Geometric Coefficient of Variation 23	345 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed Geometric Coefficient of Variation was not estimable.	820 ng/mL Geometric Coefficient of Variation 76	1865 ng/mL Geometric Coefficient of Variation 197	1511 ng/mL Geometric Coefficient of Variation 201	—	—

SECONDARY outcome

Timeframe: Days 1 and 5 of Cycle 1 (cycle length = 28 days)

Population: PK-evaluable population included all participants who received at least one dose of study treatment and who have data from at least one post dose sample.

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 Participants Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Part 1b: Cmax of Idasanutlin Metabolite M4 (Idasanutilin in Combination With Chemotherapy or Venetoclax) Cycle 1 Day 1	229 ng/mL Geometric Coefficient of Variation 56	214 ng/mL Geometric Coefficient of Variation 72	213 ng/mL Geometric Coefficient of Variation 67	—	—	—	—	—
Part 1b: Cmax of Idasanutlin Metabolite M4 (Idasanutilin in Combination With Chemotherapy or Venetoclax) Cycle 1 Day 5	442 ng/mL Geometric Coefficient of Variation 148	524 ng/mL Geometric Coefficient of Variation 97	369 ng/mL Geometric Coefficient of Variation 58	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: Predose on Days 2 and 5, 4 and 6 hours post dose on Days 1 and 5 (1 cycle = 28 days)

Population: PK-evaluable population included all participants who received at least one dose of study treatment and who have data from at least one post dose sample. Number analyzed is the number of participants with data available for analyses at the specified timepoints.

Outcome measures

Measure	Part 1a: Idasanutlin 2 mg/kg n=6 Participants Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) +Chemotherapy Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Part 1b: Plasma Concentration of Venetoclax in Combination With Idasanutlin Cycle 1 Day 1, Post dose 4 Hours	693 ng/mL Geometric Coefficient of Variation 44	—	—	—	—	—	—	—
Part 1b: Plasma Concentration of Venetoclax in Combination With Idasanutlin Cycle 1 Day 1, Post dose 6 Hours	669 ng/mL Geometric Coefficient of Variation 86	—	—	—	—	—	—	—
Part 1b: Plasma Concentration of Venetoclax in Combination With Idasanutlin Cycle 1 Day 2, Predose	202 ng/mL Geometric Coefficient of Variation 109	—	—	—	—	—	—	—
Part 1b: Plasma Concentration of Venetoclax in Combination With Idasanutlin Cycle 1 Day 5, Predose	221 ng/mL Geometric Coefficient of Variation 108	—	—	—	—	—	—	—
Part 1b: Plasma Concentration of Venetoclax in Combination With Idasanutlin Cycle 1 Day 5, Post dose 4 Hours	1145 ng/mL Geometric Coefficient of Variation 45	—	—	—	—	—	—	—
Part 1b: Plasma Concentration of Venetoclax in Combination With Idasanutlin Cycle 1 Day 5, Post dose 6 Hours	968 ng/mL Geometric Coefficient of Variation 39	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The study was terminated before initiation of Parts 2 and 3 as per sponsor's decision. No participants with leukemia were enrolled in Part 1. Hence no data were collected, and this outcome measure was not assessed or analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The study was terminated before initiation of Parts 2 and 3 as per sponsor's decision. No participants with leukemia were enrolled in Part 1. Hence no data were collected, and this outcome measure was not assessed or analyzed.

DOR, defined as the time from the first tumor assessment that supports the participant's objective response (CR, CRp, CRi) to the time of relapse, or death from any cause, whichever occurs first. CR=Bone marrow blasts <5% (AML) and no evidence of circulating blasts, must be <1% (ALL); absence of blasts with Auer rods (AML); absence of extramedullary disease; absolute neutrophil count (ANC) >1.0*10^9/L [1000µL]; platelet count > 100*10^9/L (100,000/µL); independence of transfusions for a minimum of 1 week (AML and ALL). CRi= All CR criteria except for ANC <1.0*10^9/L[1000/µL] or insufficient recovery of platelet count <100* 10^9/L [100,000/µL] (AML and ALL). CRp=All CR criteria except for ANC >1.0*10^9/L[1000/µL]) or but with insufficient recovery of platelet (<100* 10^9/L [100,000/µL]) (ALL). Relapse=participants who achieved a CR/CRp/CRi & subsequently developed: Bone marrow blasts ≥5%; reappearance of blasts in the blood ≥1%; or development of extra-medullary disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The study was terminated before initiation of Parts 2 and 3 as per sponsor's decision. No participants with leukemia were enrolled in Part 1. Hence no data were collected, and this outcome measure was not assessed or analyzed.

EFS=time from initiation of study drug to first documented occurrence of M3 marrow after Cycle 1, failure to achieve CR/CRp/CRi after Cycle 2, disease progression, relapse after achieving CR/CRp/CRi, or death from any cause, whichever occurs first. CR=Bone marrow blasts <5% (AML) & no evidence of circulating blasts, must be <1% (ALL); absence of blasts with Auer rods (AML); absence of extramedullary disease; ANC >1.0*10^9/L [1000µL]; platelet count > 100*10^9/L (100,000/µL); no transfusions for a minimum of 1 week (AML & ALL). CRi= All CR criteria except for ANC <1.0*10^9/L[1000/µL] or insufficient recovery of platelet count <100* 10^9/L [100,000/µL] (AML & ALL). CRp=All CR criteria except for ANC >1.0*10^9/L[1000/µL]) or but with insufficient recovery of platelet (<100* 10^9/L [100,000/µL]) (ALL). Relapse=participants who achieved a CR/CRp/CRi & subsequently developed: Bone marrow blasts ≥5%; reappearance of blasts in blood ≥1%; or development of extra-medullary disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The study was terminated before initiation of Part 2 and 3 as per sponsor's decision. No participants with leukemia were enrolled in Part 1. Hence no data were collected, and this outcome measure was not assessed or analyzed.

OS was defined as the time from initiation of study drug to death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The study was terminated before initiation of Part 2 and 3 as per sponsor's decision. No participants with leukemia were enrolled in Part 1. Hence no data were collected, and this outcome measure was not assessed or analyzed.

CRR was defined as the percentage of participants with CR, CRi, or CRp within 2 cycles of study treatment. CR=Bone marrow blasts <5% (AML) and no evidence of circulating blasts, must be <1% (ALL); absence of blasts with Auer rods (AML); absence of extramedullary disease; absolute neutrophil count (ANC) >1.0*10^9/L [1000/µL]; platelet count > 100*10^9/L (100,000/µL); independence of transfusions for a minimum of 1 week (AML and ALL). CRi= All CR criteria except for ANC <1.0*10^9/L[1000/µL] or insufficient recovery of platelet count <100* 10^9/L [100,000/µL] (AML and ALL). CRp=All CR criteria except for ANC >1.0*10^9/L[1000/µL]) or but with insufficient recovery of platelet (<100* 10^9/L [100,000/µL]) (ALL).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The study was terminated before initiation of Parts 2 and 3 as per sponsor's decision. No participants with leukemia were enrolled in Part 1. Hence no data were collected, and this outcome measure was not assessed or analyzed.

MRD - negative rate was defined as defined as the percentage of participants with AML who are MRD negative within 2 cycles of study treatment.

Outcome measures

Outcome data not reported

Adverse Events

Part 1a: Idasanutlin 2 mg/kg

Serious events: 6 serious events

Other events: 8 other events

Deaths: 8 deaths

Part 1a: Idasanutlin 3 mg/kg

Serious events: 3 serious events

Other events: 3 other events

Deaths: 3 deaths

Part 1a: Idasanutlin 4.5 mg/kg

Serious events: 4 serious events

Other events: 6 other events

Deaths: 6 deaths

Part 1a: Idasanutlin 6.4 mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Part 1a: Idasanutlin 8 mg/kg

Serious events: 6 serious events

Other events: 6 other events

Deaths: 5 deaths

Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1b: Idasanutlin (3.6 mg/kg) +Chemotherapy

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax

Serious events: 4 serious events

Other events: 6 other events

Deaths: 3 deaths

Serious adverse events

Measure	Part 1a: Idasanutlin 2 mg/kg n=8 participants at risk Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 participants at risk Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=6 participants at risk Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg n=3 participants at risk Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg n=6 participants at risk Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy n=3 participants at risk Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6 mg/kg) +Chemotherapy n=3 participants at risk Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax n=6 participants at risk Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Blood and lymphatic system disorders Anemia	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Blood and lymphatic system disorders Febrile neutropenia	37.5% 3/8 • Number of events 6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	50.0% 3/6 • Number of events 5 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Blood and lymphatic system disorders Hematotoxicity	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Blood and lymphatic system disorders Leukopenia	25.0% 2/8 • Number of events 4 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Blood and lymphatic system disorders Lymphopenia	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Blood and lymphatic system disorders Neutropenia	37.5% 3/8 • Number of events 7 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Blood and lymphatic system disorders Thrombocytopenia	50.0% 4/8 • Number of events 7 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Cardiac disorders Sinus tachycardia	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Ear and labyrinth disorders Hypoacusis	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Gastrointestinal disorders Nausea	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Gastrointestinal disorders Stomatitis	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Gastrointestinal disorders Vomiting	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 4 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
General disorders Pyrexia	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Appendicitis	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Bacteraemia	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Cellulitis	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Central nervous system infection	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Sepsis	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Sinusitis	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Urinary tract infection	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Injury, poisoning and procedural complications Eschar	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations Lymphocyte count decreased	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations Platelet count decreased	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations Weight decreased	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Nervous system disorders Hemorrhage intracranial	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Nervous system disorders Headache	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Nervous system disorders Partial seizures	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Nervous system disorders Seizure	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Respiratory, thoracic and mediastinal disorders Hemoptysis	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.

Other adverse events

Measure	Part 1a: Idasanutlin 2 mg/kg n=8 participants at risk Participants with solid tumors received idasanutlin 2 mg/kg QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 3 mg/kg n=3 participants at risk Participants with solid tumors received idasanutlin 3 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 4.5 mg/kg n=6 participants at risk Participants with solid tumors received idasanutlin 4.5 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 6.4 mg/kg n=3 participants at risk Participants with solid tumors received idasanutlin 6.4 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1a: Idasanutlin 8 mg/kg n=6 participants at risk Participants with solid tumors received idasanutlin 8 mg/kg orally QD on Days 1-5 of each 28-day cycle until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (2.8mg/kg) +Chemotherapy n=3 participants at risk Participants with neuroblastoma received idasanutlin 2.8 mg/kg orally in combination with cyclophosphamide 200 mg/m\^2 and topotecan 0.6 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6 mg/kg) +Chemotherapy n=3 participants at risk Participants with neuroblastoma received idasanutlin, 3.6 mg/kg orally, in combination with cyclophosphamide 250 mg/m\^2 and topotecan 0.75 mg/m\^2 as an IV infusion QD on Days 1-5 of each 28-day cycle. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.	Part 1b: Idasanutlin (3.6mg/kg) + Venetoclax n=6 participants at risk Participants with neuroblastoma (first 3) received idasanutlin, 3.6 mg/kg orally QD on Days 1-5, in combination with venetoclax 400 mg adult dose equivalent (adjusted by body weight) on Days 1-28 of each 28-day cycle. After the first three participants were treated, the schedule was modified as idasanutlin, 3.6 mg/kg orally QD on Days 1-5 and venetoclax 400 mg (adult dose equivalent) on Days 1-14 of a each 28-day cycle for the next 3 participants enrolled in this arm. Treatment was administered until disease progression, death, unacceptable toxicity, or decision to discontinue, whichever occurred first.
Blood and lymphatic system disorders Anemia	50.0% 4/8 • Number of events 5 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	50.0% 3/6 • Number of events 4 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	100.0% 6/6 • Number of events 6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	100.0% 3/3 • Number of events 4 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	100.0% 3/3 • Number of events 9 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Blood and lymphatic system disorders Leukopenia	37.5% 3/8 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	100.0% 3/3 • Number of events 8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Blood and lymphatic system disorders Lymphopenia	25.0% 2/8 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Blood and lymphatic system disorders Neutropenia	25.0% 2/8 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	100.0% 3/3 • Number of events 10 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Blood and lymphatic system disorders Thrombocytopenia	25.0% 2/8 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	50.0% 3/6 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	100.0% 3/3 • Number of events 7 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Gastrointestinal disorders Abdominal pain	37.5% 3/8 • Number of events 5 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Gastrointestinal disorders Constipation	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 4 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Gastrointestinal disorders Diarrhea	37.5% 3/8 • Number of events 4 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	83.3% 5/6 • Number of events 7 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	100.0% 3/3 • Number of events 4 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 4 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Gastrointestinal disorders Gastritis	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Gastrointestinal disorders Lip swelling	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Gastrointestinal disorders Nausea	37.5% 3/8 • Number of events 4 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 4/6 • Number of events 6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	50.0% 3/6 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 5 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	83.3% 5/6 • Number of events 6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Gastrointestinal disorders Oral pain	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Gastrointestinal disorders Stomatitis	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Gastrointestinal disorders Vomiting	50.0% 4/8 • Number of events 7 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 4/6 • Number of events 9 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 7 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 4/6 • Number of events 7 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
General disorders Asthenia	25.0% 2/8 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
General disorders Fatigue	37.5% 3/8 • Number of events 5 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
General disorders Mucosal inflammation	25.0% 2/8 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
General disorders Non-cardiac chest pain	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 5 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
General disorders Pain	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	50.0% 3/6 • Number of events 4 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
General disorders Pyrexia	37.5% 3/8 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	100.0% 3/3 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Bacteraemia	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Mucosal infection	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Oral candidiasis	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Skin infection	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Upper respiratory tract infection	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Injury, poisoning and procedural complications Contusion	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations Alanine aminotransferase increased	25.0% 2/8 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations Aspartate aminotransferase increased	50.0% 4/8 • Number of events 4 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations Blood alkaline phosphatase increased	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations Blood bicarbonate increased	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations Blood bilirubin increased	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	100.0% 3/3 • Number of events 5 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations Blood chloride decreased	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations Blood creatinine increased	12.5% 1/8 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations Blood uric acid increased	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations Gamma-glutamyltransferase increased	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	100.0% 3/3 • Number of events 4 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations Lymphocyte count decreased	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 5 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations Neutrophil count decreased	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 4 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations Platelet count decreased	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations Weight decreased	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations White blood cell count decreased	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Metabolism and nutrition disorders Decreased appetite	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Metabolism and nutrition disorders Hypoalbuminaemia	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 7 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Metabolism and nutrition disorders Hypocalcaemia	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 4 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Metabolism and nutrition disorders Hyponatraemia	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Metabolism and nutrition disorders Hypophosphataemia	12.5% 1/8 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	66.7% 2/3 • Number of events 9 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 1/8 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Musculoskeletal and connective tissue disorders Groin pain	25.0% 2/8 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Musculoskeletal and connective tissue disorders Pain in extremity	25.0% 2/8 • Number of events 4 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Nervous system disorders Headache	25.0% 2/8 • Number of events 5 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Nervous system disorders Lethargy	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Nervous system disorders Seizure	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 2/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Nervous system disorders Tremor	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Skin and subcutaneous tissue disorders Pruritus	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Skin and subcutaneous tissue disorders Rash	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Ear and labyrinth disorders Ear pain	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Eye disorders Eye pain	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Eye disorders Periorbital edema	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Gastrointestinal disorders Anal fissure	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Gastrointestinal disorders Dyspepsia	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Gastrointestinal disorders Hematochezia	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Gastrointestinal disorders Mouth swelling	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
General disorders Swelling	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
General disorders Vascular device occlusion	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations COVID-19	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Device related infection	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Fungal skin infection	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Lower respiratory tract infection	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Lymphangitis	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Nasopharyngitis	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Parainfluenzae virus infection	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Paronychia	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Infections and infestations Respiratory tract infection	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Injury, poisoning and procedural complications Accidental overdose	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations Blood lactate dehydrogenase increased	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations Blood phosphorus decreased	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Investigations SARS-CoV-2 test positive	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Musculoskeletal and connective tissue disorders Myalgia	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Nervous system disorders Dizziness	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Nervous system disorders Paraesthesia	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Psychiatric disorders Agitation	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Psychiatric disorders Anxiety	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Psychiatric disorders Confusional state	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Psychiatric disorders Insomnia	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Psychiatric disorders Irritability	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Renal and urinary disorders Dysuria	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Renal and urinary disorders Pollakiuria	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Skin and subcutaneous tissue disorders Alopecia	12.5% 1/8 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Skin and subcutaneous tissue disorders Livedo reticularis	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	16.7% 1/6 • Number of events 1 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/8 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	33.3% 1/3 • Number of events 2 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/3 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.	0.00% 0/6 • Adverse Events: From screening up to 30 days after study treatment discontinuation (approximately 7 months) All-cause mortality: From screening up to end of follow up (approximately 29 months) Safety population. One participant enrolled in idasanutlin 6.4 mg/kg cohort received a dose of 3.8 mg/kg due to maximum dose capping of 300 mg/day in protocol v3. As pre-planned, for safety evaluation and as part of the modified continual reassessment method of escalation with overdose control (mCRM) review, this participant was considered to be a part of the 6.4 mg/kg cohort in which the participant was enrolled. Thus, AEs for this participant are included in the 6.4 mg/kg cohort.

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Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER