Trial Outcomes & Findings for First in Human Study of M4344 in Participants With Advanced Solid Tumors (NCT NCT02278250)

NCT ID: NCT02278250

Last Updated: 2023-03-16

Results Overview

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, regardless if it is considered related to the medicinal product. Serious AE: AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs are defined as AEs that were reported or worsened on or after start of study drug dosing through the Safety Follow-up Visit. TEAEs included both serious TEAEs and non-serious TEAEs.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

97 participants

Primary outcome timeframe

up to safety follow-up visit (Week 124.9)

Results posted on

2023-03-16

Participant Flow

This study was planned to be conducted in multiple parts; Part A, Part A2, Part B1, Part A3 (Dose escalation), Part C1, Part C2, Part C3, Part C4, Part C5 and Part C6 (Dose expansion). On 10 December 2020, the Sponsor decided to discontinue the development of M4344 and stop enrollment of any new participants. Due to the low number of cohorts and participants, data were not summarized per Part (Part C1, C2 and C3). Also, optional Parts A3, C4, C5, and C6 were not conducted.

Participant milestones

Participant milestones
Measure
Part A: M4344 10 mg BIW
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: M4344 100 mg BID
Participants received M4344 at a dose of 100 mg orally twice daily (BID) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: M4344 150 mg QD
Participants received M4344 at a dose of 150 mg orally once daily (QD) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: M4344 250 mg QD
Participants received M4344 at a dose of 250 mg orally QD until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: M4344 350 mg QD
Participants received M4344 at a dose of 350 mg orally QD until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: M4344 350 mg + Carboplatin
Participants received M4344 at a dose of 350 mg orally on Day 2 and Day 9 in combination with intravenous infusion of Carboplatin at a dose of Area under the concentration versus time curve 5 (AUC5) on Day 1 of 21-day cycle until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: M4344 400 mg + Carboplatin
Participants received M4344 at a dose of 400 mg orally on Day 2 and Day 9 in combination with intravenous infusion of Carboplatin at a dose of AUC5 on Day 1 of 21-day cycle until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: M4344 500 mg + Carboplatin
Participants received M4344 at a dose of 500 mg orally on Day 2 and Day 9 in combination with intravenous infusion of Carboplatin at a dose of AUC5 on Day 1 of 21-day cycle until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part C: M4344 250 mg QD
Participants received M4344 at a dose of 250 mg orally QD until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Overall Study
STARTED
2
1
2
1
1
2
4
12
10
7
7
5
7
7
3
7
6
13
Overall Study
COMPLETED
2
1
2
1
1
2
4
12
10
7
7
5
7
7
3
7
6
13
Overall Study
NOT COMPLETED
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

First in Human Study of M4344 in Participants With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=2 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=4 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=12 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=10 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=7 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: M4344 100 mg BID
n=7 Participants
Participants received M4344 at a dose of 100 mg orally twice daily (BID) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: M4344 150 mg QD
n=5 Participants
Participants received M4344 at a dose of 150 mg orally once daily (QD) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: M4344 250 mg QD
n=7 Participants
Participants received M4344 at a dose of 250 mg orally QD until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: M4344 350 mg QD
n=7 Participants
Participants received M4344 at a dose of 350 mg orally QD until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: M4344 350 mg + Carboplatin
n=3 Participants
Participants received M4344 at a dose of 350 mg orally on Day 2 and Day 9 in combination with intravenous infusion of Carboplatin at a dose of Area under the concentration versus time curve 5 (AUC5) on Day 1 of 21-day cycle until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: M4344 400 mg + Carboplatin
n=7 Participants
Participants received M4344 at a dose of 400 mg orally on Day 2 and Day 9 in combination with intravenous infusion of Carboplatin at a dose of AUC5 on Day 1 of 21-day cycle until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: M4344 500 mg + Carboplatin
n=6 Participants
Participants received M4344 at a dose of 500 mg orally on Day 2 and Day 9 in combination with intravenous infusion of Carboplatin at a dose of AUC5 on Day 1 of 21-day cycle until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part C: M4344 250 mg QD
n=13 Participants
Participants received M4344 at a dose of 250 mg orally QD until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Total
n=97 Participants
Total of all reporting groups
Age, Categorical
<=18 years
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
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
0 Participants
n=136 Participants
0 Participants
n=44 Participants
0 Participants
n=667 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=8 Participants
2 Participants
n=8 Participants
8 Participants
n=24 Participants
7 Participants
n=42 Participants
6 Participants
n=42 Participants
5 Participants
n=42 Participants
2 Participants
n=42 Participants
5 Participants
n=36 Participants
4 Participants
n=36 Participants
2 Participants
n=24 Participants
3 Participants
n=135 Participants
5 Participants
n=136 Participants
9 Participants
n=44 Participants
64 Participants
n=667 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
2 Participants
n=8 Participants
4 Participants
n=24 Participants
3 Participants
n=42 Participants
1 Participants
n=42 Participants
2 Participants
n=42 Participants
3 Participants
n=42 Participants
2 Participants
n=36 Participants
3 Participants
n=36 Participants
1 Participants
n=24 Participants
4 Participants
n=135 Participants
1 Participants
n=136 Participants
4 Participants
n=44 Participants
33 Participants
n=667 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
2 Participants
n=8 Participants
0 Participants
n=8 Participants
8 Participants
n=24 Participants
6 Participants
n=42 Participants
4 Participants
n=42 Participants
3 Participants
n=42 Participants
2 Participants
n=42 Participants
4 Participants
n=36 Participants
2 Participants
n=36 Participants
0 Participants
n=24 Participants
2 Participants
n=135 Participants
3 Participants
n=136 Participants
6 Participants
n=44 Participants
45 Participants
n=667 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=8 Participants
4 Participants
n=8 Participants
4 Participants
n=24 Participants
4 Participants
n=42 Participants
3 Participants
n=42 Participants
4 Participants
n=42 Participants
3 Participants
n=42 Participants
3 Participants
n=36 Participants
5 Participants
n=36 Participants
3 Participants
n=24 Participants
5 Participants
n=135 Participants
3 Participants
n=136 Participants
7 Participants
n=44 Participants
52 Participants
n=667 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
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
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
0 Participants
n=136 Participants
0 Participants
n=44 Participants
0 Participants
n=667 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
2 Participants
n=8 Participants
4 Participants
n=8 Participants
12 Participants
n=24 Participants
9 Participants
n=42 Participants
5 Participants
n=42 Participants
6 Participants
n=42 Participants
4 Participants
n=42 Participants
7 Participants
n=36 Participants
6 Participants
n=36 Participants
2 Participants
n=24 Participants
4 Participants
n=135 Participants
5 Participants
n=136 Participants
12 Participants
n=44 Participants
85 Participants
n=667 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
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
1 Participants
n=42 Participants
2 Participants
n=42 Participants
1 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=36 Participants
1 Participants
n=36 Participants
1 Participants
n=24 Participants
3 Participants
n=135 Participants
1 Participants
n=136 Participants
1 Participants
n=44 Participants
12 Participants
n=667 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
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
0 Participants
n=136 Participants
0 Participants
n=44 Participants
0 Participants
n=667 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
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
1 Participants
n=136 Participants
0 Participants
n=44 Participants
1 Participants
n=667 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
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
0 Participants
n=136 Participants
0 Participants
n=44 Participants
0 Participants
n=667 Participants
Race (NIH/OMB)
Black or African American
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
1 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
0 Participants
n=136 Participants
0 Participants
n=44 Participants
2 Participants
n=667 Participants
Race (NIH/OMB)
White
2 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=8 Participants
4 Participants
n=8 Participants
12 Participants
n=24 Participants
8 Participants
n=42 Participants
5 Participants
n=42 Participants
4 Participants
n=42 Participants
2 Participants
n=42 Participants
7 Participants
n=36 Participants
6 Participants
n=36 Participants
2 Participants
n=24 Participants
4 Participants
n=135 Participants
3 Participants
n=136 Participants
12 Participants
n=44 Participants
77 Participants
n=667 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
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
0 Participants
n=24 Participants
0 Participants
n=135 Participants
0 Participants
n=136 Participants
0 Participants
n=44 Participants
0 Participants
n=667 Participants
Race (NIH/OMB)
Unknown or Not Reported
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
2 Participants
n=42 Participants
2 Participants
n=42 Participants
3 Participants
n=42 Participants
2 Participants
n=42 Participants
0 Participants
n=36 Participants
1 Participants
n=36 Participants
1 Participants
n=24 Participants
3 Participants
n=135 Participants
2 Participants
n=136 Participants
1 Participants
n=44 Participants
17 Participants
n=667 Participants

PRIMARY outcome

Timeframe: up to safety follow-up visit (Week 124.9)

Population: The safety analysis set (SAF) included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg.

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, regardless if it is considered related to the medicinal product. Serious AE: AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs are defined as AEs that were reported or worsened on or after start of study drug dosing through the Safety Follow-up Visit. TEAEs included both serious TEAEs and non-serious TEAEs.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=2 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=4 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=12 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=10 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=7 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
2 Participants
1 Participants
2 Participants
1 Participants
1 Participants
2 Participants
4 Participants
12 Participants
10 Participants
7 Participants

PRIMARY outcome

Timeframe: up to safety follow-up visit (Week 124.9)

Population: The safety analysis set (SAF) included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg.

Laboratory parameters: hematology and chemistry. Blood samples were collected for analysis of following hematology parameters: Hemoglobin, Erythrocytes, mean corpuscular hemoglobin (MCH), MCH concentration, Mean corpuscular volume, Reticulocytes, Platelets, Leukocytes, Eosinophils, Basophils, Neutrophils, Lymphocytes, Monocytes. Blood samples were collected for analysis of following chemistry parameters: Glucose, Blood urea nitrogen/Urea, Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium, Bicarbonate, Inorganic phosphate, Total bilirubin, Direct bilirubin, Total protein, Albumin, Creatine kinase, Alkaline phosphatase, Aspartate aminotransferase, Alanine aminotransferase, Lactate dehydrogenase, Uric acid, Thyroid stimulating hormone. Number of participants with Grade 3 or 4 (\>20% of total) in laboratory parameters were reported as per NCI-CTCAE v4.0 graded from Grade 1 to 5. Grade 1: Mild, Grade 2: Moderate; Grade 3: Severe. Grade 4: Life-threatening and Grade 5: Death.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=2 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=4 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=12 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=10 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=7 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.0)
Hematology
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Part A: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.0)
Total Bilirubin
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
5 Participants
6 Participants
4 Participants

PRIMARY outcome

Timeframe: up to safety follow-up visit (Week 124.9)

Population: The safety analysis set (SAF) included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg.

Vital signs included body temperature, heart rate, systolic and diastolic blood pressure and respiration rate. Number of participants with clinically relevant findings in vital signs were reported. Clinical relevance was decided by Investigator.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=2 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=4 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=12 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=10 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=7 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Number of Participants With Clinically Relevant Findings in Vital Signs
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: up to safety follow-up visit (Week 124.9)

Population: The safety analysis set (SAF) included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg.

ECG parameters included PR interval, RR interval, QT interval, QRS duration, QTc intervals (derived using Fridericia's correction method) and heart rate. A 12-lead ECG was recorded with the participant in a supine position after a rest of at least 5 minutes using an ECG machine. Clinical significance was decided by investigator. Number of participants with clinically significant abnormalities in 12-Lead ECGs were reported.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=2 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=4 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=12 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=10 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=7 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
1 Participants

PRIMARY outcome

Timeframe: up to Cycle 1 (each cycle is of 21 days)

Population: Dose Limiting Toxicity (DLT) Evaluable Set: included all enrolled participants who received at least 1 dose of M4344 and either: Experienced a DLT before the end of Cycle 1 or Received at least 80% of scheduled M4344 doses through the end of Cycle 1.

MTD as per NCI-CTCAE v4.0 is defined as highest dose for a given schedule at which there is no more than 1 dose- limiting toxicity (DLT) in 6 participants. DLT: as related/possibly drug-related: Neutropenia Grade (Gr)4 for \> 7 days duration/requiring hemopoietic growth factors; Febrile neutropenia; Infection with Gr3/4 neutropenia; Thrombocytopenia Gr3; Thrombocytopenia Gr4 for \> 7 days duration/requiring hemopoietic growth factors; Gr3/4 toxicity to organs other than bone marrow; Gr3/4 increase in bilirubin unless increase is due to inhibition of bilirubin glucuronidation; Death due to drug-related complications; Cardiac: QTc prolongation, Gr2/greater ventricular arrhythmia, severe sustained/symptomatic sinus bradycardia, persistent supraventricular arrhythmia, Symptoms suggestive of congestive heart failure, Troponin-T level consistent with myocardial infarction; drug-related toxicity causes interruption of treatment for \> 2 weeks.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=42 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Maximum Tolerated Dose (MTD) of M4344 Administered Twice Weekly (BIW)
NA milligrams (mg)
MTD not determined as development focus of the study shifted to daily monotherapy dosing (Part A2).

PRIMARY outcome

Timeframe: up to safety follow-up visit (Week 39)

Population: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg.

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, regardless if it is considered related to the medicinal product. Serious AE: AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs are defined as AEs that were reported or worsened on or after start of study drug dosing through the Safety Follow-up Visit. TEAEs included both serious TEAEs and non-serious TEAEs.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=7 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=5 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=7 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=7 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
7 Participants
5 Participants
7 Participants
7 Participants

PRIMARY outcome

Timeframe: up to safety follow-up visit (Week 39)

Population: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg.

Laboratory parameters: hematology and chemistry. Blood samples were collected for analysis of following hematology parameters: Hemoglobin, Erythrocytes, mean corpuscular hemoglobin (MCH), MCH concentration, Mean corpuscular volume, Reticulocytes, Platelets, Leukocytes, Eosinophils, Basophils, Neutrophils, Lymphocytes, Monocytes. Blood samples were collected for analysis of following chemistry parameters: Glucose, Blood urea nitrogen/Urea, Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium, Bicarbonate, Inorganic phosphate, Total bilirubin, Direct bilirubin, Total protein, Albumin, Creatine kinase, Alkaline phosphatase, Aspartate aminotransferase, Alanine aminotransferase, Lactate dehydrogenase, Uric acid, Thyroid stimulating hormone. Number of participants with Grade 3 or 4 (\>20% of total) in laboratory parameters were reported as per NCI-CTCAE v5.0 graded from Grade 1 to 5. Grade 1: Mild, Grade 2: Moderate; Grade 3: Severe. Grade 4: Life-threatening and Grade 5: Death.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=7 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=5 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=7 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=7 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0)
Low lymphocytes
1 Participants
1 Participants
2 Participants
3 Participants
Part A2: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0)
Total Bilirubin
3 Participants
2 Participants
3 Participants
3 Participants
Part A2: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0)
Aspartate Aminotransferase
2 Participants
1 Participants
0 Participants
4 Participants
Part A2: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0)
Alanine Aminotransferase
2 Participants
2 Participants
0 Participants
3 Participants

PRIMARY outcome

Timeframe: up to safety follow-up visit (Week 39)

Population: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg.

Vital signs included body temperature, heart rate, systolic and diastolic blood pressure and respiration rate. Number of participants with clinically relevant findings were reported. Clinical relevance was decided by Investigator.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=7 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=5 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=7 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=7 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Number of Participants With Clinically Relevant Findings in Vital Signs
0 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: up to safety follow-up visit (Week 39)

Population: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg.

ECG parameters included PR interval, RR interval, QT interval, QRS duration, QTc intervals (derived using Fridericia's correction method) and heart rate. A 12-lead ECG was recorded with the participant in a supine position after a rest of at least 5 minutes using an ECG machine. Clinical Significance was determined by investigator. Number of participants with clinically significant abnormalities in 12-lead ECGs were reported.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=7 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=5 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=7 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=7 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs)
0 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: up to Cycle 1 (each cycle is of 21 days)

Population: DLT evaluable set included all enrolled participants who received at least one dose of M4344 and either: Experienced a DLT before the end of Cycle 1 or Received at least 80% of scheduled M4344 doses through the end of Cycle 1.

MTD as per NCI-CTCAE v5.0 is defined as highest dose for a given schedule at which there is no more than 1 dose- limiting toxicity (DLT) in 6 participants. DLT: as related/possibly drug-related: Neutropenia Grade (Gr)4 for \> 7 days duration/requiring hemopoietic growth factors; Febrile neutropenia; Infection with Gr3/4 neutropenia; Thrombocytopenia Gr3; Thrombocytopenia Gr4 for \> 7 days duration/requiring hemopoietic growth factors; Gr3/4 toxicity to organs other than bone marrow; Gr3/4 increase in bilirubin unless increase is due to inhibition of bilirubin glucuronidation; Death due to drug-related complications; Cardiac: QTc prolongation, Gr2/greater ventricular arrhythmia, severe sustained/symptomatic sinus bradycardia, persistent supraventricular arrhythmia, Symptoms suggestive of congestive heart failure, Troponin-T level consistent with myocardial infarction; drug-related toxicity causes interruption of treatment for \> 2 weeks.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=26 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Maximum Tolerated Dose (MTD) of M4344 Administered With a Dose Dense Schedule
250 mg

PRIMARY outcome

Timeframe: up to Safety follow-up (Week 92.3)

Population: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg.

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, regardless if it is considered related to the medicinal product. Serious AE: AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs are defined as AEs that were reported or worsened on or after start of study drug dosing through the Safety Follow-up Visit. TEAEs included both serious TEAEs and non-serious TEAEs.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=3 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=7 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=6 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
3 Participants
7 Participants
6 Participants

PRIMARY outcome

Timeframe: up to Safety follow-up (Week 92.3)

Population: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg.

Laboratory parameters: hematology and chemistry. Blood samples were collected for analysis of following hematology parameters: Hemoglobin, Erythrocytes, mean corpuscular hemoglobin (MCH), MCH concentration, Mean corpuscular volume, Reticulocytes, Platelets, Leukocytes, Eosinophils, Basophils, Neutrophils, Lymphocytes, Monocytes. Blood samples were collected for analysis of following chemistry parameters: Glucose, Blood urea nitrogen/Urea, Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium, Bicarbonate, Inorganic phosphate, Total bilirubin, Direct bilirubin, Total protein, Albumin, Creatine kinase, Alkaline phosphatase, Aspartate aminotransferase, Alanine aminotransferase, Lactate dehydrogenase, Uric acid, Thyroid stimulating hormone. Number of participants with Grade 3 or 4 (\>20% of total) in laboratory parameters were reported as per NCI-CTCAE v4.0 graded from Grade 1 to 5. Grade 1: Mild, Grade 2: Moderate; Grade 3: Severe. Grade 4: Life-threatening and Grade 5: Death.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=3 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=7 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=6 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.0)
Low Leukocytes
0 Participants
1 Participants
4 Participants
Part B1: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.0)
Low lymphocytes
1 Participants
3 Participants
1 Participants
Part B1: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.0)
Chemistry
0 Participants
0 Participants
0 Participants
Part B1: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.0)
Neutrophils
1 Participants
1 Participants
5 Participants
Part B1: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.0)
Platelets
1 Participants
3 Participants
3 Participants
Part B1: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.0)
Low hemoglobin
1 Participants
4 Participants
1 Participants

PRIMARY outcome

Timeframe: up to Safety follow-up (Week 92.3)

Population: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg.

Vital signs included body temperature, heart rate, systolic and diastolic blood pressure and respiration rate. Number of participants with clinically relevant findings in vital signs were reported. Clinical relevance was decided by Investigator.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=3 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=7 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=6 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: Number of Participants With Clinically Relevant Findings in Vital Signs
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: up to Safety follow-up (Week 92.3)

Population: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg.

ECG parameters included PR interval, RR interval, QT interval, QRS duration, QTc intervals (derived using Fridericia's correction method) and heart rate. A 12-lead ECG was recorded with the participant in a supine position after a rest of at least 5 minutes using an ECG machine. Clinical significance was determined by Investigator. Number of participants with clinically significant abnormalities in 12-lead ECGs were reported.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=3 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=7 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=6 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs)
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: up to Cycle 1 (each cycle is of 21 days)

Population: DLT evaluable set included all enrolled participants who received at least one dose of M4344 and either: Experienced a DLT before the end of Cycle 1 or Received Carboplatin dose on Day 1 and M4344 dose on Days 2 and 9.

MTD as per NCI-CTCAE v4.0 is defined as highest dose for a given schedule at which there is no more than 1 dose- limiting toxicity (DLT) in 6 participants. DLT: as related/possibly drug-related: Neutropenia Grade (Gr)4 for \> 7 days duration/requiring hemopoietic growth factors; Febrile neutropenia; Infection with Gr3/4 neutropenia; Thrombocytopenia Gr3; Thrombocytopenia Gr4 for \> 7 days duration/requiring hemopoietic growth factors; Gr3/4 toxicity to organs other than bone marrow; Gr3/4 increase in bilirubin unless increase is due to inhibition of bilirubin glucuronidation; Death due to drug-related complications; Cardiac: QTc prolongation, Gr2/greater ventricular arrhythmia, severe sustained/symptomatic sinus bradycardia, persistent supraventricular arrhythmia, Symptoms suggestive of congestive heart failure, Troponin-T level consistent with myocardial infarction; drug-related toxicity causes interruption of treatment for \> 2 weeks.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=16 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: Maximum Tolerated Dose (MTD) of M4344 (Monotherapy) Administered in Combination With Carboplatin
NA mg
MTD not determined as development focus of the study shifted to daily monotherapy dosing (Part A2).

PRIMARY outcome

Timeframe: up to Safety follow-up (Week 31.1)

Population: The SAF included all participants who received at least one dose of study drug.

AE: any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of a medicinal product, regardless if it is considered related to medicinal product. Serious AE: AE that resulted in any of following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: AEs that were reported/worsened on/after start of study drug dosing through the Safety Follow-up Visit. TEAEs included both serious TEAEs and non-serious TEAEs. Treatment related AEs: reasonably related to the study drug/study treatment. AE could medically (pharmacologically/clinically) be attributed to the study drug/study treatment under study in this clinical study protocol.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=13 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Related AEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Participants with TEAEs
13 Participants
Part C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Related AEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Participants with Treatment related AEs
13 Participants

PRIMARY outcome

Timeframe: up to Safety follow-up (Week 31.1)

Population: The SAF included all participants who received at least one dose of study drug.

Laboratory parameters: hematology and chemistry. Blood samples were collected for analysis of following hematology parameters: Hemoglobin, Erythrocytes, mean corpuscular hemoglobin (MCH), MCH concentration, Mean corpuscular volume, Reticulocytes, Platelets, Leukocytes, Eosinophils, Basophils, Neutrophils, Lymphocytes, Monocytes. Blood samples were collected for analysis of following chemistry parameters: Glucose, Blood urea nitrogen/Urea, Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium, Bicarbonate, Inorganic phosphate, Total bilirubin, Direct bilirubin, Total protein, Albumin, Creatine kinase, Alkaline phosphatase, Aspartate aminotransferase, Alanine aminotransferase, Lactate dehydrogenase, Uric acid, Thyroid stimulating hormone. Number of participants with Grade 3 or 4 (\>20% of total) in laboratory parameters were reported as per NCI-CTCAE v5.0 graded from Grade 1 to 5. Grade 1: Mild, Grade 2: Moderate; Grade 3: Severe. Grade 4: Life-threatening and Grade 5: Death.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=13 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part C: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0)
Low lymphocytes
8 Participants
Part C: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0)
Low hemoglobin
6 Participants
Part C: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0)
Total Bilirubin
7 Participants
Part C: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0)
Aspartate Aminotransferase
4 Participants
Part C: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0)
Alanine Aminotransferase
3 Participants

PRIMARY outcome

Timeframe: up to Safety follow-up (Week 31.1)

Population: The SAF included all participants who received at least one dose of study drug.

Vital signs included body temperature, heart rate, systolic and diastolic blood pressure and respiration rate. Number of participants with clinically relevant findings in vital signs were reported. Clinical relevance was decided by Investigator.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=13 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part C: Number of Participants With Clinically Relevant Findings in Vital Signs
0 Participants

PRIMARY outcome

Timeframe: up to Safety follow-up (Week 31.1)

Population: The SAF included all participants who received at least one dose of study drug.

ECG parameters included PR interval, RR interval, QT interval, QRS duration, QTc intervals (derived using Fridericia's correction method) and heart rate. A 12-lead ECG was recorded with the participant in a supine position after a rest of at least 5 minutes using an ECG machine. Clinical significance was determined by investigator. Number of participants with clinically significant abnormalities in 12-lead ECGs were reported.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=13 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part C: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs)
6 Participants

PRIMARY outcome

Timeframe: Time from first dose of study treatment up to 6.4 years

Population: Full Analysis Set (FAS) included all participants who received at least one dose of study drug.

OR is defined as the confirmed assessment of best overall response of complete response (CR) or partial response (PR). CR is defined as disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=13 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part C: Percentage of Participants With Objective Response (OR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator
0.0 percentage of participants
Interval 0.0 to 20.6

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The Pharmacokinetic Analysis Set (PAS) included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

Cmax was obtained directly from the plasma concentration versus time curve.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=2 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=4 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=12 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=10 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=7 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Maximum Observed Plasma Concentration (Cmax) of M4344
Cycle 1 Day 1
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
376 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 64.2
516 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 83.6
395 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 73.2
576 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 79.9
Part A: Maximum Observed Plasma Concentration (Cmax) of M4344
Cycle 1 Day 8
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
342 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 136.6
675 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 65.7
328 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 313.1
486 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 23.8

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=2 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=4 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=12 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=10 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=7 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Area Under the Plasma Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of M4344
Cycle 1 Day 1
NA nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
948 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 56.4
1830 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 102.0
1390 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 64.5
2220 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 105.9
Part A: Area Under the Plasma Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of M4344
Cycle 1 Day 8
NA nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
809 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 96.6
2670 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 91.2
1550 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 295.1
1880 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 74.0

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Cycle 1 Day 1 (each cycle is of 21 days)

Population: The Pharmacokinetic Analysis Set (PAS) included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLOQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=2 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=4 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=10 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=6 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=3 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M4344
NA ng*h/mL
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
971 ng*h/mL
Geometric Coefficient of Variation 53.6
1710 ng*h/mL
Geometric Coefficient of Variation 92.5
1760 ng*h/mL
Geometric Coefficient of Variation 122.3
1540 ng*h/mL
Geometric Coefficient of Variation 128.9

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

Tmax was obtained directly from the plasma concentration versus time curve.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=2 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=4 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=12 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=10 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=7 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Time to Reach Maximum Plasma Concentration (Tmax) of M4344
Cycle 1 Day 1
NA hours
Median and Full range were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Median and Full range were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Median and Full range were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Median and Full range were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Median and Full range were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Median and Full range were not to be calculated if fewer than 3 participants have reportable parameter values.
1.51 hours
Interval 0.663 to 2.15
2.00 hours
Interval 0.533 to 8.0
2.06 hours
Interval 1.5 to 4.0
3.07 hours
Interval 1.5 to 4.07
Part A: Time to Reach Maximum Plasma Concentration (Tmax) of M4344
Cycle 1 Day 8
NA hours
Median and Full range were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Median and Full range were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Median and Full range were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Median and Full range were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Median and Full range were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Median and Full range were not to be calculated if fewer than 3 participants have reportable parameter values.
1.22 hours
Interval 1.05 to 1.5
2.00 hours
Interval 1.57 to 3.95
4.00 hours
Interval 1.52 to 8.05
3.95 hours
Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

Elimination Half Life (T1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half. T1/2 was calculated by natural log 2 divided by Lambda z. Lambda z was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=2 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=4 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=10 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=6 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=3 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Terminal Elimination Half-Life (T1/2) of M4344
Cycle 1 Day 1
NA hours
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
2.22 hours
Geometric Coefficient of Variation 99.0
3.33 hours
Geometric Coefficient of Variation 42.3
4.61 hours
Geometric Coefficient of Variation 65.2
3.60 hours
Geometric Coefficient of Variation 39.9
Part A: Terminal Elimination Half-Life (T1/2) of M4344
Cycle 1 Day 8
NA hours
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA hours
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
2.19 hours
Geometric Coefficient of Variation 220.1
3.11 hours
Geometric Coefficient of Variation 64.2
NA hours
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

CL/f was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. CL/f was calculated as Dose/AUC0-inf, where AUC0-inf was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. AUC0-inf was calculated as AUC0-t + Clast pred/Lambda Z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the lower limit of quantification (LLQ) and Lambda Z was the apparent terminal rate constant determined from the terminal slope of the log-transformed plasma concentration curve.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=2 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=4 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=10 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=6 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=3 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Apparent Clearance (CL/f) of M4344
Cycle 1 Day 1
NA liter per hour
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liter per hour
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liter per hour
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liter per hour
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liter per hour
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liter per hour
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
464 liter per hour
Geometric Coefficient of Variation 53.6
409 liter per hour
Geometric Coefficient of Variation 92.5
597 liter per hour
Geometric Coefficient of Variation 122.3
781 liter per hour
Geometric Coefficient of Variation 128.9
Part A: Apparent Clearance (CL/f) of M4344
Cycle 1 Day 8
NA liter per hour
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liter per hour
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liter per hour
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liter per hour
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liter per hour
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liter per hour
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
513 liter per hour
Geometric Coefficient of Variation 78.2
221 liter per hour
Geometric Coefficient of Variation 114.3
NA liter per hour
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

Vz/f: the distribution of a study drug between plasma and the rest of the body after oral dosing. For single dose Vz/f = Dose/(AUC0-inf\*Lambda Z), where AUC0-inf = (AUC0-t + Clast pred/Lambda Z). Clastpred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the LLOQ and Lambda Z = the apparent terminal rate constant determined from the terminal slope of the log-transformed plasma concentration curve.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=2 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=4 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=10 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=6 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=3 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Apparent Volume of Distribution During Terminal Phase (Vz/f) of M4344
Cycle 1 Day 8
NA liters
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liters
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liters
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liters
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liters
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liters
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
1620 liters
Geometric Coefficient of Variation 716.8
993 liters
Geometric Coefficient of Variation 59.6
NA liters
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
Part A: Apparent Volume of Distribution During Terminal Phase (Vz/f) of M4344
Cycle 1 Day 1
NA liters
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liters
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liters
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liters
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liters
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA liters
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
1480 liters
Geometric Coefficient of Variation 187.9
1960 liters
Geometric Coefficient of Variation 116.0
3970 liters
Geometric Coefficient of Variation 95.8
4060 liters
Geometric Coefficient of Variation 211.6

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Accumulation ratio of Cmax was calculated as Cmax, after dosing on Day 8 divided by Cmax, after dosing on Day 1 of Cycle 1.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=1 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=3 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=7 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=6 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=3 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Accumulation Ratio for Maximum Observed Plasma Concentration (Racc [Cmax]) of M4344
NA ratio
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ratio
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ratio
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ratio
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ratio
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ratio
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
0.988 ratio
Geometric Coefficient of Variation 37.9
1.19 ratio
Geometric Coefficient of Variation 67.5
1.01 ratio
Geometric Coefficient of Variation 163.2
1.55 ratio
Geometric Coefficient of Variation 17.4

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Accumulation ratio of AUC0-t was calculated as AUC0-t, after dosing on Day 8 divided by AUC0-t, after dosing on Day 1 of Cycle 1.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=1 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=3 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=7 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=6 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=3 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Accumulation Ratio for Area Under the Plasma Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (Racc [AUC0-t]) of M4344
NA ratio
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ratio
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ratio
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ratio
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ratio
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ratio
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
0.955 ratio
Geometric Coefficient of Variation 23.7
1.46 ratio
Geometric Coefficient of Variation 77.8
1.36 ratio
Geometric Coefficient of Variation 163.7
1.89 ratio
Geometric Coefficient of Variation 33.6

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

Dose normalized was calculated as Cmax obtained directly from the concentration versus time curve divided by dose. Cmax/dose was measured in nanogram per milliliter per milligram (ng/mL/mg).

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=2 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=4 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=12 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=10 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=7 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax/Dose) of M4344
Cycle 1 Day 1
NA ng/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
0.835 ng/mL/mg
Geometric Coefficient of Variation 64.2
0.738 ng/mL/mg
Geometric Coefficient of Variation 83.6
0.376 ng/mL/mg
Geometric Coefficient of Variation 73.2
0.480 ng/mL/mg
Geometric Coefficient of Variation 79.9
Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax/Dose) of M4344
Cycle 1 Day 8
NA ng/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
0.760 ng/mL/mg
Geometric Coefficient of Variation 136.6
0.964 ng/mL/mg
Geometric Coefficient of Variation 65.7
0.312 ng/mL/mg
Geometric Coefficient of Variation 313.1
0.405 ng/mL/mg
Geometric Coefficient of Variation 23.8

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

AUC0-t/Dose was defined as AUC from time of dosing to the time of the last measurable concentration divided by dose. AUC0-t/dose was measured in nanogram\*hour per milliliter per milligram (ng\*h/mL/mg).

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=2 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=4 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=12 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=10 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=7 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Dose Normalized Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t/Dose) of M4344
Cycle 1 Day 8
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
1.80 ng*h/mL/mg
Geometric Coefficient of Variation 96.6
3.82 ng*h/mL/mg
Geometric Coefficient of Variation 91.2
1.47 ng*h/mL/mg
Geometric Coefficient of Variation 295.1
1.57 ng*h/mL/mg
Geometric Coefficient of Variation 74.0
Part A: Dose Normalized Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t/Dose) of M4344
Cycle 1 Day 1
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
2.11 ng*h/mL/mg
Geometric Coefficient of Variation 56.4
2.61 ng*h/mL/mg
Geometric Coefficient of Variation 102.0
1.32 ng*h/mL/mg
Geometric Coefficient of Variation 64.5
1.85 ng*h/mL/mg
Geometric Coefficient of Variation 105.9

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, and 24 hours post-dose on Cycle 1 Day 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

AUC0-inf/Dose was defined as AUC extrapolated to infinity divided by dose.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=2 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=4 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=10 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=6 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=3 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Dose Normalized Area Under the Concentration-Time Curve Over Entire Dosing Time Period From Time Zero Extrapolated to Infinity (AUC0-inf/Dose) of M4344
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
2.16 ng*h/mL/mg
Geometric Coefficient of Variation 53.6
2.45 ng*h/mL/mg
Geometric Coefficient of Variation 92.5
1.68 ng*h/mL/mg
Geometric Coefficient of Variation 122.3
1.28 ng*h/mL/mg
Geometric Coefficient of Variation 128.9

SECONDARY outcome

Timeframe: Time from first dose of study treatment up to 4.3 years

Population: Full analysis set (FAS): all enrolled participants who satisfy all of the following criteria: received at least 1 dose of study drug with the actual amount \> 0 mg; have a baseline scan with a measurable target lesion (sum of diameters of all target lesions \> 0 mm) and have at least 1 disease assessment on treatment with a measurable target lesion (sum of diameters of all target lesions \>= 0 mm); or subjects who have discontinued the study due to either progressive disease or death.

The OR was defined as the confirmed assessment of best overall response (BOR) of partial response (PR),or complete response (CR) according to RECIST v1.1. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=1 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=1 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=1 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=3 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=6 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=7 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=4 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Percentage of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
0.0 percentage of participants
Interval 0.0 to 95.0
0.0 percentage of participants
Interval 0.0 to 95.0
0.0 percentage of participants
Interval 0.0 to 95.0
0.0 percentage of participants
Interval 0.0 to 95.0
0.0 percentage of participants
Interval 0.0 to 95.0
0.0 percentage of participants
Interval 0.0 to 95.0
0.0 percentage of participants
Interval 0.0 to 63.2
0.0 percentage of participants
Interval 0.0 to 39.3
0.0 percentage of participants
Interval 0.0 to 34.8
0.0 percentage of participants
Interval 0.0 to 52.7

SECONDARY outcome

Timeframe: Time from first dose of study treatment up to 4.3 years

Population: FAS: all enrolled participants who satisfy all of the following criteria: received at least 1 dose of study drug with the actual amount \> 0 mg; have a baseline scan with a measurable target lesion (sum of diameters of all target lesions \> 0 mm) and have at least 1 disease assessment on treatment with a measurable target lesion (sum of diameters of all target lesions \>= 0 mm); or subjects who have discontinued the study due to either progressive disease or death.

SD is defined as neither sufficient increase to qualify for progression disease (PD) nor sufficient shrinkage to qualify for partial response (PR). PR: at least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions. PD: at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=1 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=1 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 Participants
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=1 Participants
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=3 Participants
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=6 Participants
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=7 Participants
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=4 Participants
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: Number of Participants With Stable Disease (SD) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
2 Participants
2 Participants
1 Participants
1 Participants

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable at specified time points.

Cmax was obtained directly from the plasma concentration versus time curve.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=6 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=5 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=7 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=7 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Maximum Observed Plasma Concentration (Cmax) of M4344
Cycle 1 Day 8
114 ng/mL
Geometric Coefficient of Variation 32.3
244 ng/mL
Geometric Coefficient of Variation 59.3
379 ng/mL
Geometric Coefficient of Variation 88.9
NA ng/mL
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
Part A2: Maximum Observed Plasma Concentration (Cmax) of M4344
Cycle 1 Day 1
111 ng/mL
Geometric Coefficient of Variation 40.3
124 ng/mL
Geometric Coefficient of Variation 392.2
517 ng/mL
Geometric Coefficient of Variation 78.3
265 ng/mL
Geometric Coefficient of Variation 152.7

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose on Cycle 1 Day 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLOQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=6 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=5 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=6 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=7 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M4344
217 ng*h/mL
Geometric Coefficient of Variation 44.2
436 ng*h/mL
Geometric Coefficient of Variation 127.4
1210 ng*h/mL
Geometric Coefficient of Variation 95.0
680 ng*h/mL
Geometric Coefficient of Variation 144.1

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 (in BID arms), 24 hours post-dose (in QD arms) on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=6 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=5 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=7 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=7 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Area Under the Plasma Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of M4344
Cycle 1 Day 1
216 ng*h/mL
Geometric Coefficient of Variation 43.2
414 ng*h/mL
Geometric Coefficient of Variation 142.9
1230 ng*h/mL
Geometric Coefficient of Variation 86.1
703 ng*h/mL
Geometric Coefficient of Variation 142.7
Part A2: Area Under the Plasma Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of M4344
Cycle 1 Day 8
236 ng*h/mL
Geometric Coefficient of Variation 55.4
627 ng*h/mL
Geometric Coefficient of Variation 58.9
829 ng*h/mL
Geometric Coefficient of Variation 101.4
NA ng*h/mL
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

Tmax was obtained directly from the plasma concentration versus time curve.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=6 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=5 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=7 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=7 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Time to Reach Maximum Plasma Concentration (Tmax) of M4344
Cycle 1 Day 8
1.03 hours
Interval 1.0 to 1.43
1.28 hours
Interval 0.5 to 2.0
1.50 hours
Interval 0.5 to 1.95
NA hours
Median and Full range were not to be calculated if fewer than 3 participants have reportable parameter values.
Part A2: Time to Reach Maximum Plasma Concentration (Tmax) of M4344
Cycle 1 Day 1
1.45 hours
Interval 0.517 to 2.0
1.62 hours
Interval 0.467 to 2.07
1.50 hours
Interval 0.5 to 2.0
1.10 hours
Interval 0.683 to 3.02

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

Elimination Half Life (T1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half. T1/2 was calculated by natural log 2 divided by Lambda z. Lambda z was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=6 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=5 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=7 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=7 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Terminal Elimination Half-Life (T1/2) of M4344
Cycle 1 Day 1
1.32 hours
Geometric Coefficient of Variation 27.1
2.47 hours
Geometric Coefficient of Variation 165.9
1.74 hours
Geometric Coefficient of Variation 58.8
2.37 hours
Geometric Coefficient of Variation 60.9
Part A2: Terminal Elimination Half-Life (T1/2) of M4344
Cycle 1 Day 8
1.36 hours
Geometric Coefficient of Variation 58.7
1.31 hours
Geometric Coefficient of Variation 28.9
1.31 hours
Geometric Coefficient of Variation 18.7
NA hours
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

CL/f was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. CL/f was calculated as Dose/AUC0-inf, where AUC0-inf was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. AUC0-inf was calculated as AUC0-t + Clast pred/Lambda Z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the lower limit of quantification (LLQ) and Lambda Z was the apparent terminal rate constant determined from the terminal slope of the log-transformed plasma concentration curve.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=6 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=5 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=7 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=7 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Apparent Clearance (CL/f) of M4344
Cycle 1 Day 1
461 liter per hour
Geometric Coefficient of Variation 44.2
344 liter per hour
Geometric Coefficient of Variation 127.4
207 liter per hour
Geometric Coefficient of Variation 95.0
515 liter per hour
Geometric Coefficient of Variation 144.1
Part A2: Apparent Clearance (CL/f) of M4344
Cycle 1 Day 8
424 liter per hour
Geometric Coefficient of Variation 55.4
239 liter per hour
Geometric Coefficient of Variation 58.9
302 liter per hour
Geometric Coefficient of Variation 101.4
NA liter per hour
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose on Cycle 1 Day 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Vz/f: the distribution of a study drug between plasma and the rest of the body after oral dosing. For single dose Vz/f = Dose/(AUC0-inf\*Lambda Z), where AUC0-inf = (AUC0-t + Clast pred/Lambda Z). Clastpred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the LLOQ and Lambda Z = the apparent terminal rate constant determined from the terminal slope of the log-transformed plasma concentration curve.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=6 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=5 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=6 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=7 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Apparent Volume of Distribution During Terminal Phase (Vz/f) of M4344
876 liters
Geometric Coefficient of Variation 36.3
1220 liters
Geometric Coefficient of Variation 661.7
519 liters
Geometric Coefficient of Variation 191.1
1760 liters
Geometric Coefficient of Variation 214.7

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Accumulation ratio of Cmax was calculated as Cmax, after dosing on Day 8 divided by Cmax, after dosing on Day 1 of Cycle 1.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=3 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=4 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=7 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=2 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Accumulation Ratio for Maximum Observed Plasma Concentration (Racc [Cmax]) of M4344
1.08 ratio
Geometric Coefficient of Variation 47.5
2.26 ratio
Geometric Coefficient of Variation 245.2
0.733 ratio
Geometric Coefficient of Variation 92.1
NA ratio
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 (in BID arms), 24 hours post-dose (in QD arms) on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Accumulation ratio of AUC0-t was calculated as AUC0-t, after dosing on Day 8 divided by AUC0-t, after dosing on Day 1 of Cycle 1.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=3 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=4 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=7 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=2 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Accumulation Ratio for Area Under the Plasma Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (Racc [AUC0-t]) of M4344
1.00 ratio
Geometric Coefficient of Variation 55.3
1.42 ratio
Geometric Coefficient of Variation 142.4
0.672 ratio
Geometric Coefficient of Variation 90.7
NA ratio
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Accumulation ratio of AUC was calculated as AUC, after dosing on Day 8 divided by AUC, after dosing on Day 1 of Cycle 1.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=3 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=4 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=7 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=2 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Accumulation Ratio for Area Under the Plasma Concentration Time Curve (Racc [AUC]) of M4344
0.997 ratio
Geometric Coefficient of Variation 55.7
1.32 ratio
Geometric Coefficient of Variation 133.5
0.676 ratio
Geometric Coefficient of Variation 88.4
NA ratio
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

Dose normalized was calculated as Cmax obtained directly from the concentration versus time curve divided by dose. Cmax/dose was measured in nanogram per milliliter per milligram (ng/mL/mg).

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=6 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=5 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=7 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=7 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Dose Normalized Maximum Observed Plasma Concentration (Cmax/Dose) of M4344
Cycle 1 Day 1
1.11 ng/mL/mg
Geometric Coefficient of Variation 40.3
0.829 ng/mL/mg
Geometric Coefficient of Variation 392.2
2.07 ng/mL/mg
Geometric Coefficient of Variation 78.3
0.758 ng/mL/mg
Geometric Coefficient of Variation 152.7
Part A2: Dose Normalized Maximum Observed Plasma Concentration (Cmax/Dose) of M4344
Cycle 1 Day 8
1.14 ng/mL/mg
Geometric Coefficient of Variation 32.3
1.63 ng/mL/mg
Geometric Coefficient of Variation 59.3
1.52 ng/mL/mg
Geometric Coefficient of Variation 88.9
NA ng/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose on Cycle 1 Day 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

AUC0-inf/Dose was defined as AUC extrapolated to infinity divided by dose. AUC0-inf/Dose was measured in nanogram\*hour per milliliter per milligram (ng\*h/mL/mg).

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=6 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=5 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=6 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=7 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Dose Normalized Area Under the Concentration-Time Curve Over Entire Dosing Time Period From Time Zero Extrapolated to Infinity (AUC0-inf/Dose) of M4344
2.17 ng*h/mL/mg
Geometric Coefficient of Variation 44.2
2.91 ng*h/mL/mg
Geometric Coefficient of Variation 127.4
4.84 ng*h/mL/mg
Geometric Coefficient of Variation 95.0
1.94 ng*h/mL/mg
Geometric Coefficient of Variation 144.1

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 (in BID arms), 24 hours post-dose (in QD arms) on Day 1 and Day 8 of Cycle 1 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.

AUC0-t/Dose was defined as AUC from time of dosing to the time of the last measurable concentration divided by dose.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=6 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=5 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=7 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=7 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Dose Normalized Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t/Dose) of M4344
Cycle 1 Day 1
2.16 ng*h/mL/mg
Geometric Coefficient of Variation 43.2
2.76 ng*h/mL/mg
Geometric Coefficient of Variation 142.9
4.93 ng*h/mL/mg
Geometric Coefficient of Variation 86.1
2.01 ng*h/mL/mg
Geometric Coefficient of Variation 142.7
Part A2: Dose Normalized Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t/Dose) of M4344
Cycle 1 Day 8
2.36 ng*h/mL/mg
Geometric Coefficient of Variation 55.4
4.18 ng*h/mL/mg
Geometric Coefficient of Variation 58.9
3.32 ng*h/mL/mg
Geometric Coefficient of Variation 101.4
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.

SECONDARY outcome

Timeframe: Time from first dose of study treatment up to 6.2 years

Population: FAS is defined as all enrolled participants who received at least 1 dose of study drug, have a baseline scan, and received at least one disease assessment while on treatment.

SD is defined as neither sufficient increase to qualify for progression disease (PD) nor sufficient shrinkage to qualify for partial response (PR). PR: at least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions. PD: at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=7 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=4 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=7 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=5 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Number of Participants With Stable Disease (SD) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
1 Participants
1 Participants
4 Participants
2 Participants

SECONDARY outcome

Timeframe: Time from first dose of study treatment up to 6.2 years

Population: FAS is defined as all enrolled participants who received at least 1 dose of study drug, have a baseline scan, and received at least one disease assessment while on treatment.

The OR was defined as the confirmed assessment of best overall response (BOR) of partial response (PR),or complete response (CR) according to RECIST v1.1. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=7 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=4 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=7 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=5 Participants
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: Percentage of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
0.0 percentage of participants
Interval 0.0 to 34.8
0.0 percentage of participants
Interval 0.0 to 52.7
0.0 percentage of participants
Interval 0.0 to 34.8
0.0 percentage of participants
Interval 0.0 to 45.1

SECONDARY outcome

Timeframe: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Cycle 1 Day 2 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received.

Cmax was obtained directly from the plasma concentration versus time curve.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=3 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=7 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=6 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: Maximum Observed Plasma Concentration (Cmax) of M4344
309 ng/mL
Geometric Coefficient of Variation 78.1
114 ng/mL
Geometric Coefficient of Variation 191.6
367 ng/mL
Geometric Coefficient of Variation 89.8

SECONDARY outcome

Timeframe: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Cycle 1 Day 2 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received.

Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=3 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=7 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=6 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: Area Under the Plasma Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of M4344
392 ng*h/mL
Geometric Coefficient of Variation 101.8
268 ng*h/mL
Geometric Coefficient of Variation 179.6
1450 ng*h/mL
Geometric Coefficient of Variation 115.6

SECONDARY outcome

Timeframe: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Cycle 1 Day 2 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLOQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=4 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=3 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M4344
NA ng*h/mL
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
368 ng*h/mL
Geometric Coefficient of Variation 147.3
2570 ng*h/mL
Geometric Coefficient of Variation 124.3

SECONDARY outcome

Timeframe: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Cycle 1 Day 2 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received.

Tmax was obtained directly from the plasma concentration versus time curve.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=3 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=7 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=6 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1:Time to Reach Maximum Plasma Concentration (Tmax) of M4344
1.52 hours
Interval 0.9 to 2.0
1.50 hours
Interval 0.5 to 8.02
1.96 hours
Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Cycle 1 Day 2 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Elimination Half Life (T1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half. T1/2 was calculated by natural log 2 divided by Lambda z. Lambda z was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=4 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=3 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: Terminal Elimination Half-Life (T1/2) of M4344
NA hours
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
1.03 hours
Geometric Coefficient of Variation 23.6
3.77 hours
Geometric Coefficient of Variation 59.1

SECONDARY outcome

Timeframe: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Cycle 1 Day 2 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

CL/f was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. CL/f was calculated as Dose/AUC0-inf, where AUC0-inf was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. AUC0-inf was calculated as AUC0-t + Clast pred/Lambda Z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the lower limit of quantification (LLQ) and Lambda Z was the apparent terminal rate constant determined from the terminal slope of the log-transformed plasma concentration curve.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=4 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=3 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: Apparent Clearance (CL/f) of M4344
NA liter per hour
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
1090 liter per hour
Geometric Coefficient of Variation 147.3
194 liter per hour
Geometric Coefficient of Variation 124.3

SECONDARY outcome

Timeframe: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Cycle 1 Day 2 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Vz/f: the distribution of a study drug between plasma and the rest of the body after oral dosing. For single dose Vz/f = Dose/(AUC0-inf\*Lambda Z), where AUC0-inf = (AUC0-t + Clast pred/Lambda Z). Clastpred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the LLOQ and Lambda Z = the apparent terminal rate constant determined from the terminal slope of the log-transformed plasma concentration curve.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=4 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=3 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: Apparent Volume of Distribution During Terminal Phase (Vz/f) of M4344
NA liters
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
1620 liters
Geometric Coefficient of Variation 155.5
1060 liters
Geometric Coefficient of Variation 45.1

SECONDARY outcome

Timeframe: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Cycle 1 Day 2 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received.

Dose normalized was calculated as Cmax obtained directly from the concentration versus time curve divided by dose.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=3 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=7 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=6 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: Dose Normalized Maximum Observed Plasma Concentration (Cmax/Dose) of M4344
0.884 ng/mL/mg
Geometric Coefficient of Variation 78.1
0.286 ng/mL/mg
Geometric Coefficient of Variation 191.6
0.735 ng/mL/mg
Geometric Coefficient of Variation 89.8

SECONDARY outcome

Timeframe: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Cycle 1 Day 2 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received.

AUC0-t/Dose was defined as AUC from time of dosing to the time of the last measurable concentration divided by dose.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=3 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=7 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=6 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: Dose Normalized Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t/Dose) of M4344
1.12 ng*h/mL/mg
Geometric Coefficient of Variation 101.8
0.669 ng*h/mL/mg
Geometric Coefficient of Variation 179.6
2.90 ng*h/mL/mg
Geometric Coefficient of Variation 115.6

SECONDARY outcome

Timeframe: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours post-dose on Cycle 1 Day 2 (each cycle is of 21 days)

Population: The PAS included all enrolled participants who received at least one dose of M4344 with the actual amount \> 0 mg and provide at least one measurable post-dose concentration. Participants were analyzed according to the actual treatment they received. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

AUC0-inf/Dose was defined as AUC extrapolated to infinity divided by dose.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=2 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=4 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=3 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: Dose Normalized Area Under the Concentration-Time Curve Over Entire Dosing Time Period From Time Zero Extrapolated to Infinity (AUC0-inf/Dose) of M4344
NA ng*h/mL/mg
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation were not to be calculated if fewer than 3 participants have reportable parameter values.
0.920 ng*h/mL/mg
Geometric Coefficient of Variation 147.3
5.15 ng*h/mL/mg
Geometric Coefficient of Variation 124.3

SECONDARY outcome

Timeframe: Time from first dose of study treatment up to 5.2 years

Population: FAS is defined as all enrolled participants who received at least 1 dose of study treatment, have a baseline scan with a measurable target lesion, and at least one on-treatment disease assessment or have discontinued the study due to either progressive disease or death.

The OR was defined as the confirmed assessment of best overall response (BOR) of partial response (PR),or complete response (CR) according to RECIST v1.1. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=3 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=7 Participants
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=6 Participants
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: Percentage of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
0.0 percentage of participants
Interval 0.0 to 63.2
14.3 percentage of participants
Interval 0.7 to 52.1
0.0 percentage of participants
Interval 0.0 to 39.3

SECONDARY outcome

Timeframe: Time from first dose of study treatment up to 6.4 years

Population: FAS included all participants who received at least one dose of study drug.

Confirmed BOR is defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the treatment start date until documented disease progression. CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30%reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=13 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part C: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
Complete response (CR)
0 Participants
Part C: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
Partial response (PR)
0 Participants
Part C: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
Stable disease (SD)
3 Participants
Part C: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
Progressive disease (PD)
8 Participants
Part C: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
Non-CR/Non-PD
0 Participants
Part C: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
Non-evaluable
2 Participants

SECONDARY outcome

Timeframe: Time from first dose of study treatment up to 6.4 years

Population: FAS included all participants who received at least one dose of study drug.

PFS is defined as the time from start of study treatment to progression disease (PD) or death. PD: at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=13 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part C: Progression-Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 as Assessed by Investigator
1.6 months
Interval 0.8 to 2.1

SECONDARY outcome

Timeframe: Time from first documentation of objective response, assessed up to 6.4 years

Population: As per planned analysis, DoR was not analyzed due to the small number of participants and the low likelihood that any participant would experience an objective response.

DOR was defined for participants with confirmed response, as the time from first documentation of objective response (Complete Response \[CR\] or Partial Response \[PR\]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first dose of study treatment up to 6.4 years

Population: FAS included all participants who received at least one dose of study drug. The summarized data was not available for these arms therefore individual data was presented. Here, "Overall Number of Participants" signifies those participants who were evaluable for this outcome measure and "number analyzed" = specific participants evaluated in the arm.

OS was defined as the time from treatment start to the date of death due to any cause. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date. OS was measured using Kaplan-Meier (KM) estimates.

Outcome measures

Outcome measures
Measure
Part A: M4344 10 mg BIW
n=6 Participants
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part C: Overall Survival (OS)
Participant 1
1.91 months
Part C: Overall Survival (OS)
Participant 2
0.79 months
Part C: Overall Survival (OS)
Participant 3
1.61 months
Part C: Overall Survival (OS)
Participant 4
3.98 months
Part C: Overall Survival (OS)
Participant 5
2.53 months
Part C: Overall Survival (OS)
Participant 6
2.63 months

SECONDARY outcome

Timeframe: Pre-dose up to 2 hours post-dose on Cycle 1 Day 1; Pre-dose up to 1 hours post-dose on Cycle 1 Day 8 and Cycle 1 Day 15 (each cycle is of 21 days)

Population: As per changes in planned analysis, the outcome measures related to pharmacokinetic parameters were not assessed for Part C.

Cmax was obtained directly from the plasma concentration versus time curve.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose up to 2 hours post-dose on Cycle 1 Day 1; Pre-dose up to 1 hours post-dose on Cycle 1 Day 8 and Cycle 1 Day 15 (each cycle is of 21 days)

Population: As per changes in planned analysis, the outcome measures related to pharmacokinetic parameters were not assessed for Part C.

Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose up to 2 hours post-dose on Cycle 1 Day 1; Pre-dose up to 1 hours post-dose on Cycle 1 Day 8 and Cycle 1 Day 15 (each cycle is of 21 days)

Population: As per changes in planned analysis, the outcome measures related to pharmacokinetic parameters were not assessed for Part C.

Tmax was obtained directly from the plasma concentration versus time curve.

Outcome measures

Outcome data not reported

Adverse Events

Part A: M4344 10 mg BIW

Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths

Part A: M4344 20 mg BIW

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Part A: M4344 40 mg BIW

Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths

Part A: M4344 80 mg BIW

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Part A: M4344 160 mg BIW

Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths

Part A: M4344 300 mg BIW

Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths

Part A: M4344 450 mg BIW

Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths

Part A: M4344 700 mg BIW

Serious events: 6 serious events
Other events: 12 other events
Deaths: 8 deaths

Part A: M4344 1050 mg BIW

Serious events: 6 serious events
Other events: 10 other events
Deaths: 3 deaths

Part A: M4344 1200 mg BIW

Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths

Part A2: M4344 100 mg BID

Serious events: 5 serious events
Other events: 7 other events
Deaths: 5 deaths

Part A2: M4344 150 mg QD

Serious events: 1 serious events
Other events: 5 other events
Deaths: 3 deaths

Part A2: M4344 250 mg QD

Serious events: 2 serious events
Other events: 7 other events
Deaths: 2 deaths

Part A2: M4344 350 mg QD

Serious events: 5 serious events
Other events: 7 other events
Deaths: 3 deaths

Part B1: M4344 350 mg + Carboplatin

Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths

Part B1: M4344 400 mg + Carboplatin

Serious events: 4 serious events
Other events: 7 other events
Deaths: 4 deaths

Part B1: M4344 500 mg + Carboplatin

Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths

Part C: M4344 250 mg QD

Serious events: 7 serious events
Other events: 13 other events
Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure
Part A: M4344 10 mg BIW
n=2 participants at risk
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 participants at risk
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=2 participants at risk
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 participants at risk
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 participants at risk
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 participants at risk
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=4 participants at risk
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=12 participants at risk
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=10 participants at risk
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=7 participants at risk
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: M4344 100 mg BID
n=7 participants at risk
Participants received M4344 at a dose of 100 mg orally twice daily (BID) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: M4344 150 mg QD
n=5 participants at risk
Participants received M4344 at a dose of 150 mg orally once daily (QD) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: M4344 250 mg QD
n=7 participants at risk
Participants received M4344 at a dose of 250 mg orally QD until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: M4344 350 mg QD
n=7 participants at risk
Participants received M4344 at a dose of 350 mg orally QD until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: M4344 350 mg + Carboplatin
n=3 participants at risk
Participants received M4344 at a dose of 350 mg orally on Day 2 and Day 9 in combination with intravenous infusion of Carboplatin at a dose of Area under the concentration versus time curve 5 (AUC5) on Day 1 of 21-day cycle until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: M4344 400 mg + Carboplatin
n=7 participants at risk
Participants received M4344 at a dose of 400 mg orally on Day 2 and Day 9 in combination with intravenous infusion of Carboplatin at a dose of AUC5 on Day 1 of 21-day cycle until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: M4344 500 mg + Carboplatin
n=6 participants at risk
Participants received M4344 at a dose of 500 mg orally on Day 2 and Day 9 in combination with intravenous infusion of Carboplatin at a dose of AUC5 on Day 1 of 21-day cycle until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part C: M4344 250 mg QD
n=13 participants at risk
Participants received M4344 at a dose of 250 mg orally QD until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Gastrointestinal disorders
Abdominal pain
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Nausea
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
1/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
1/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Vomiting
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
1/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Disease progression
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
15.4%
2/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Pyrexia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Immune system disorders
Hypersensitivity
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
1/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Infections and infestations
Upper respiratory tract infection
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Infections and infestations
Urosepsis
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Injury, poisoning and procedural complications
Fall
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Alanine aminotransferase increased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Aspartate aminotransferase increased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Blood bilirubin increased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
57.1%
4/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Nervous system disorders
Cauda equina syndrome
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Renal and urinary disorders
Acute kidney injury
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Diarrhoea
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Pancreatitis
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Fatigue
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Malaise
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Infections and infestations
Biliary sepsis
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
20.0%
1/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Infections and infestations
Pneumonia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Infections and infestations
Sepsis
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Transaminases increased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Metabolism and nutrition disorders
Dehydration
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Nervous system disorders
Seizure
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Nervous system disorders
Somnolence
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
2/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Abdominal distension
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Gastrointestinal inflammation
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Death
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Euthanasia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Immune system disorders
Anaphylactic reaction
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Nervous system disorders
Syncope
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Blood and lymphatic system disorders
Anaemia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Intestinal obstruction
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Hepatobiliary disorders
Biliary obstruction
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Hepatobiliary disorders
Hepatic failure
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Infections and infestations
Streptococcal infection
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.

Other adverse events

Other adverse events
Measure
Part A: M4344 10 mg BIW
n=2 participants at risk
Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 20 mg BIW
n=1 participants at risk
Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 40 mg BIW
n=2 participants at risk
Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 80 mg BIW
n=1 participants at risk
Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 160 mg BIW
n=1 participants at risk
Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 300 mg BIW
n=2 participants at risk
Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 450 mg BIW
n=4 participants at risk
Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 700 mg BIW
n=12 participants at risk
Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1050 mg BIW
n=10 participants at risk
Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A: M4344 1200 mg BIW
n=7 participants at risk
Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: M4344 100 mg BID
n=7 participants at risk
Participants received M4344 at a dose of 100 mg orally twice daily (BID) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: M4344 150 mg QD
n=5 participants at risk
Participants received M4344 at a dose of 150 mg orally once daily (QD) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: M4344 250 mg QD
n=7 participants at risk
Participants received M4344 at a dose of 250 mg orally QD until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part A2: M4344 350 mg QD
n=7 participants at risk
Participants received M4344 at a dose of 350 mg orally QD until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: M4344 350 mg + Carboplatin
n=3 participants at risk
Participants received M4344 at a dose of 350 mg orally on Day 2 and Day 9 in combination with intravenous infusion of Carboplatin at a dose of Area under the concentration versus time curve 5 (AUC5) on Day 1 of 21-day cycle until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: M4344 400 mg + Carboplatin
n=7 participants at risk
Participants received M4344 at a dose of 400 mg orally on Day 2 and Day 9 in combination with intravenous infusion of Carboplatin at a dose of AUC5 on Day 1 of 21-day cycle until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part B1: M4344 500 mg + Carboplatin
n=6 participants at risk
Participants received M4344 at a dose of 500 mg orally on Day 2 and Day 9 in combination with intravenous infusion of Carboplatin at a dose of AUC5 on Day 1 of 21-day cycle until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Part C: M4344 250 mg QD
n=13 participants at risk
Participants received M4344 at a dose of 250 mg orally QD until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.
Psychiatric disorders
Insomnia
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Platelet count decreased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
White blood cell count decreased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
White blood cell count increased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Haemoglobin decreased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Neutrophil count increased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Metabolism and nutrition disorders
Decreased appetite
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
2/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
42.9%
3/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
66.7%
2/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
15.4%
2/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Metabolism and nutrition disorders
Dehydration
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
20.0%
1/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
2/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
42.9%
3/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Metabolism and nutrition disorders
Hypophosphataemia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
1/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
1/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Musculoskeletal and connective tissue disorders
Bone pain
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Musculoskeletal and connective tissue disorders
Groin pain
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
1/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Musculoskeletal and connective tissue disorders
Myalgia
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Musculoskeletal and connective tissue disorders
Pain in jaw
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Musculoskeletal and connective tissue disorders
Limb discomfort
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour obstruction
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Nervous system disorders
Disturbance in attention
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Nervous system disorders
Dizziness
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Nervous system disorders
Headache
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
2/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
1/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
1/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Nervous system disorders
Sinus headache
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Nervous system disorders
Memory impairment
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
20.0%
1/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Nervous system disorders
Ophthalmic migraine
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Nervous system disorders
Neuropathy peripheral
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Psychiatric disorders
Anxiety
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Psychiatric disorders
Depression
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Renal and urinary disorders
Acute kidney injury
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Renal and urinary disorders
Chromaturia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Renal and urinary disorders
Chronic kidney disease
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Renal and urinary disorders
Dysuria
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Renal and urinary disorders
Haematuria
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Renal and urinary disorders
Pollakiuria
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Renal and urinary disorders
Urinary incontinence
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Renal and urinary disorders
Hydronephrosis
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
1/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
1/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
2/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
57.1%
4/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
1/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
1/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Reproductive system and breast disorders
Pelvic pain
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Reproductive system and breast disorders
Vaginal haemorrhage
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Reproductive system and breast disorders
Breast pain
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Skin and subcutaneous tissue disorders
Angioedema
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
1/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
1/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Skin and subcutaneous tissue disorders
Rash pruritic
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
20.0%
1/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Skin and subcutaneous tissue disorders
Skin discolouration
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Skin and subcutaneous tissue disorders
Skin burning sensation
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Surgical and medical procedures
Tooth extraction
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Vascular disorders
Hot flush
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Vascular disorders
Hypotension
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Vascular disorders
Peripheral coldness
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
1/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Vascular disorders
Vena cava thrombosis
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Vascular disorders
Hypertension
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Blood and lymphatic system disorders
Anaemia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
1/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
40.0%
2/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
57.1%
4/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
1/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
57.1%
4/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
3/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
53.8%
7/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
66.7%
2/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
3/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Cardiac disorders
Atrial fibrillation
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Ear and labyrinth disorders
Vertigo
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Eye disorders
Ocular hyperaemia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Abdominal distension
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Abdominal pain
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
1/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
30.0%
3/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Abdominal pain upper
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Constipation
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
2/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
75.0%
3/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
57.1%
4/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
20.0%
1/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
15.4%
2/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Diarrhoea
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
1/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
3/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
40.0%
2/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
15.4%
2/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Dry mouth
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Dyspepsia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
2/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Flatulence
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
1/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
1/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Nausea
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
2/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
2/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
66.7%
8/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
60.0%
6/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
71.4%
5/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
42.9%
3/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
40.0%
2/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
57.1%
4/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
66.7%
2/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
3/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
46.2%
6/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Post-tussive vomiting
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Stomatitis
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Vomiting
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
1/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
58.3%
7/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
40.0%
4/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
57.1%
4/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
71.4%
5/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
42.9%
3/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
1/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
61.5%
8/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
66.7%
2/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
57.1%
4/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
66.7%
4/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Cardiac disorders
Palpitations
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Eye disorders
Dry eye
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Eye disorders
Vision blurred
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
20.0%
1/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Eye disorders
Conjunctival haemorrhage
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Eye disorders
Retinal haemorrhage
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Duodenal obstruction
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Eructation
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Gastrointestinal disorders
Mouth ulceration
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Asthenia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Chills
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Fatigue
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
2/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
58.3%
7/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
5/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
42.9%
3/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
42.9%
3/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
60.0%
3/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
71.4%
5/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
42.9%
3/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
3/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
57.1%
4/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
83.3%
5/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
23.1%
3/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Influenza like illness
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Infusion site swelling
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Non-cardiac chest pain
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
2/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Oedema peripheral
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
2/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
15.4%
2/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Pain
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
20.0%
2/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Pyrexia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
1/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
42.9%
3/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
42.9%
3/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
23.1%
3/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Chest pain
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Malaise
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Oedema
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
General disorders
Peripheral swelling
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Hepatobiliary disorders
Cholelithiasis
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Hepatobiliary disorders
Hepatic failure
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Hepatobiliary disorders
Hepatic function abnormal
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
2/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
30.0%
3/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Hepatobiliary disorders
Jaundice
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
15.4%
2/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Hepatobiliary disorders
Ocular icterus
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Immune system disorders
Drug hypersensitivity
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
1/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Immune system disorders
Hypersensitivity
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Infections and infestations
Epididymitis
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Infections and infestations
Gastroenteritis viral
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Infections and infestations
Nasopharyngitis
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Infections and infestations
Oral candidiasis
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Infections and infestations
Oral herpes
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Infections and infestations
Pneumonia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
1/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Infections and infestations
Sinusitis
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Infections and infestations
Upper respiratory tract infection
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Infections and infestations
Furuncle
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Infections and infestations
Urinary tract infection
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
42.9%
3/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
23.1%
3/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Mean cell volume increased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Infections and infestations
Respiratory tract infection
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
1/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Injury, poisoning and procedural complications
Fall
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Injury, poisoning and procedural complications
Arthropod bite
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Injury, poisoning and procedural complications
Incisional hernia
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
1/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Injury, poisoning and procedural complications
Radiation skin injury
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Alanine aminotransferase increased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
70.0%
7/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
57.1%
4/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
40.0%
2/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
71.4%
5/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
1/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
2/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
76.9%
10/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Aspartate aminotransferase increased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
90.0%
9/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
57.1%
4/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
42.9%
3/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
40.0%
2/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
57.1%
4/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
16.7%
1/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
84.6%
11/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Blood alkaline phosphatase increased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
10.0%
1/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
38.5%
5/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Blood bilirubin increased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
3/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
40.0%
4/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
57.1%
4/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
20.0%
1/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
57.1%
4/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
1/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
61.5%
8/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Blood creatinine increased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
1/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Blood lactate dehydrogenase increased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
50.0%
1/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Electrocardiogram QT prolonged
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
8.3%
1/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Gamma-glutamyltransferase increased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
20.0%
2/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
28.6%
2/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
33.3%
1/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Lymphocyte count decreased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
25.0%
1/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
7.7%
1/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Neutrophil count decreased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Weight decreased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
20.0%
1/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Weight increased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
100.0%
1/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Hepatic enzyme increase
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Transaminases increased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
Investigations
Blood urea increased
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/1 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/2 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/4 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/12 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/10 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/5 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/3 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
14.3%
1/7 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/6 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.
0.00%
0/13 • Part A: up to Safety follow-up (Week 124.9), Part A2: up to Safety follow-up ( Week 39), Part B1: up to Safety follow-up (Week 92.3) and Part C: up to Safety follow-up (Week 31.1)
Part A, A2 and B1: The SAF included all enrolled participants who received at least 1 dose of study drug (either M4344 or carboplatin (Part B1 only) with the actual amount \> 0 mg. Part C: The SAF included all participants who received at least one dose of study drug. For Part A and B: MedDRA version 23.0 and for Part A2 and C: MedDRA version 24.0.

Additional Information

Communication Center

Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Results disclosure agreements

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

Restriction type: OTHER