Trial Outcomes & Findings for A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors. (NCT NCT02734004)

NCT ID: NCT02734004

Last Updated: 2026-01-29

Results Overview

The DCR at 12 weeks was defined as the percentage of participants who had complete response (CR) + partial response (PR) + stable disease (SD) at 12 weeks. Participants demonstrated SD for a minimum interval of 11 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 77 days) following the start of treatment. The DCR was determined using Investigator assessments according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

264 participants

Primary outcome timeframe

RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019.

Results posted on

2026-01-29

Participant Flow

This Phase I/II open-label study was conducted in participants with advanced solid tumors at 43 centers in France, the United Kingdom, the Republic of Korea, the USA, the Netherlands, Israel, and Switzerland. Initial stage cohorts: Results are reported for analysis with assessment until data cut-off (DCO) of 14 Jun 2019 \[except for overall survival (OS) for ovarian cancer cohort (DCO: 17 Sep 2021)\]. Second stage cohorts: Results are reported for analysis with assessment until DCO of 17 Sep 2021.

This study consists a screening period (28 days), run-in monotherapy treatment period (initial stage cohort only; 4 weeks) followed by combination therapy treatment period until progressive disease (PD). 148 participants entered initial stage cohorts and 114 participants entered second stage cohorts. Thus, 262 participants were enrolled in the study.

Participant milestones

Participant milestones
Measure
Initial Stage: Small Cell Lung Cancer
Participants received monotherapy with olaparib 300 milligram (mg) orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 grams (g) intravenous (IV) infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kilogram (kg) IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Overall Study
STARTED
40
34
34
40
51
31
32
Overall Study
COMPLETED
0
0
0
0
0
0
0
Overall Study
NOT COMPLETED
40
34
34
40
51
31
32

Reasons for withdrawal

Reasons for withdrawal
Measure
Initial Stage: Small Cell Lung Cancer
Participants received monotherapy with olaparib 300 milligram (mg) orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 grams (g) intravenous (IV) infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kilogram (kg) IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Overall Study
Death
36
24
26
35
13
17
20
Overall Study
Lost to Follow-up
1
1
0
0
1
0
0
Overall Study
Withdrawal by Subject
3
1
1
1
3
0
2
Overall Study
Other
0
8
7
4
34
14
10

Baseline Characteristics

A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Initial Stage: Small Cell Lung Cancer
n=38 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
n=30 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
n=32 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
n=39 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
n=51 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Triplet
n=31 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
n=32 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Total
n=253 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=35 Participants
0 Participants
n=4328 Participants
0 Participants
n=8687 Participants
0 Participants
n=153 Participants
0 Participants
n=200 Participants
0 Participants
n=12 Participants
0 Participants
n=4 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
23 Participants
n=35 Participants
29 Participants
n=4328 Participants
27 Participants
n=8687 Participants
29 Participants
n=153 Participants
38 Participants
n=200 Participants
17 Participants
n=12 Participants
12 Participants
n=4 Participants
175 Participants
n=5 Participants
Age, Categorical
>=65 years
15 Participants
n=35 Participants
1 Participants
n=4328 Participants
5 Participants
n=8687 Participants
10 Participants
n=153 Participants
13 Participants
n=200 Participants
14 Participants
n=12 Participants
20 Participants
n=4 Participants
78 Participants
n=5 Participants
Sex: Female, Male
Female
17 Participants
n=35 Participants
29 Participants
n=4328 Participants
32 Participants
n=8687 Participants
13 Participants
n=153 Participants
51 Participants
n=200 Participants
31 Participants
n=12 Participants
32 Participants
n=4 Participants
205 Participants
n=5 Participants
Sex: Female, Male
Male
21 Participants
n=35 Participants
1 Participants
n=4328 Participants
0 Participants
n=8687 Participants
26 Participants
n=153 Participants
0 Participants
n=200 Participants
0 Participants
n=12 Participants
0 Participants
n=4 Participants
48 Participants
n=5 Participants
Race/Ethnicity, Customized
White
21 Participants
n=35 Participants
17 Participants
n=4328 Participants
22 Participants
n=8687 Participants
24 Participants
n=153 Participants
34 Participants
n=200 Participants
20 Participants
n=12 Participants
24 Participants
n=4 Participants
162 Participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
0 Participants
n=35 Participants
0 Participants
n=4328 Participants
0 Participants
n=8687 Participants
0 Participants
n=153 Participants
1 Participants
n=200 Participants
0 Participants
n=12 Participants
0 Participants
n=4 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
6 Participants
n=35 Participants
7 Participants
n=4328 Participants
6 Participants
n=8687 Participants
13 Participants
n=153 Participants
12 Participants
n=200 Participants
10 Participants
n=12 Participants
3 Participants
n=4 Participants
57 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
0 Participants
n=35 Participants
0 Participants
n=4328 Participants
0 Participants
n=8687 Participants
0 Participants
n=153 Participants
0 Participants
n=200 Participants
1 Participants
n=12 Participants
0 Participants
n=4 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Missing
11 Participants
n=35 Participants
6 Participants
n=4328 Participants
4 Participants
n=8687 Participants
2 Participants
n=153 Participants
4 Participants
n=200 Participants
0 Participants
n=12 Participants
5 Participants
n=4 Participants
32 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic or Latino
0 Participants
n=35 Participants
0 Participants
n=4328 Participants
0 Participants
n=8687 Participants
0 Participants
n=153 Participants
0 Participants
n=200 Participants
1 Participants
n=12 Participants
0 Participants
n=4 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
27 Participants
n=35 Participants
24 Participants
n=4328 Participants
28 Participants
n=8687 Participants
37 Participants
n=153 Participants
47 Participants
n=200 Participants
30 Participants
n=12 Participants
27 Participants
n=4 Participants
220 Participants
n=5 Participants

PRIMARY outcome

Timeframe: RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019.

Population: The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).

The DCR at 12 weeks was defined as the percentage of participants who had complete response (CR) + partial response (PR) + stable disease (SD) at 12 weeks. Participants demonstrated SD for a minimum interval of 11 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 77 days) following the start of treatment. The DCR was determined using Investigator assessments according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Outcome measures

Outcome measures
Measure
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Small Cell Lung Cancer
n=38 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
n=30 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
n=32 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
n=39 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage Cohorts: Disease Control Rate (DCR) at Week 12
28.9 percentage of participants
80.0 percentage of participants
81.3 percentage of participants
25.6 percentage of participants

PRIMARY outcome

Timeframe: RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.

Population: The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).

The ORR (based on RECIST 1.1 as assessed by the Investigator) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD or last evaluable assessment in the absence of progression. The 95% confidence interval (CI) were calculated using Exact Clopper-Pearson confidence limits for the binomial proportion.

Outcome measures

Outcome measures
Measure
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Small Cell Lung Cancer
n=51 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage Cohort: Objective Response Rate (ORR)
92.2 percentage of participants
Interval 81.12 to 97.82

PRIMARY outcome

Timeframe: RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.

Population: The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).

The DCR at 24 weeks was defined as the percentage of participants who had CR + PR + SD at 24 weeks. Participants demonstrated SD for a minimum interval of 23 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 161 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.

Outcome measures

Outcome measures
Measure
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Small Cell Lung Cancer
n=31 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
n=32 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage Cohorts: DCR at Week 24
74.2 percentage of participants
28.1 percentage of participants

SECONDARY outcome

Timeframe: RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.

Population: The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).

The DCR at 24 weeks was defined as the percentage of participants who had CR + PR + SD at 24 weeks. Participants demonstrated SD for a minimum interval of 23 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 161 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.

Outcome measures

Outcome measures
Measure
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Small Cell Lung Cancer
n=51 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage Expansion Cohort: DCR at Week 24
88.2 percentage of participants

SECONDARY outcome

Timeframe: RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019.

Population: The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).

The DCR at 28 weeks was defined as the percentage of participants who had CR + PR + SD at 28 weeks. Participants demonstrated SD for a minimum interval of 27 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 189 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.

Outcome measures

Outcome measures
Measure
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Small Cell Lung Cancer
n=38 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
n=30 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
n=32 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
n=39 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage Cohorts: DCR at Week 28
5.3 percentage of participants
50.0 percentage of participants
65.6 percentage of participants
7.7 percentage of participants

SECONDARY outcome

Timeframe: RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.

Population: The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).

The DCR at 56 weeks was defined as the percentage of participants who had CR + PR + SD at 56 weeks. Participants demonstrated SD for a minimum interval of 55 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 385 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.

Outcome measures

Outcome measures
Measure
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Small Cell Lung Cancer
n=51 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
n=31 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
n=32 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage Cohorts: DCR at Week 56
41.2 percentage of participants
38.7 percentage of participants
9.4 percentage of participants

SECONDARY outcome

Timeframe: RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively

Population: The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).

The ORR (based on RECIST 1.1 as assessed by the Investigator) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD or last evaluable assessment in the absence of progression. The 95% CI were calculated using Exact Clopper-Pearson confidence limits for the binomial proportion.

Outcome measures

Outcome measures
Measure
Second Stage: Ovarian Cancer Triplet
n=32 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Small Cell Lung Cancer
n=38 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
n=30 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
n=32 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
n=39 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
n=31 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial and Second Stage Cohorts: ORR
34.4 percentage of participants
Interval 18.57 to 53.19
10.5 percentage of participants
Interval 2.94 to 24.8
63.3 percentage of participants
Interval 43.86 to 80.07
71.9 percentage of participants
Interval 53.25 to 86.25
10.3 percentage of participants
Interval 2.87 to 24.22
87.1 percentage of participants
Interval 70.17 to 96.37

SECONDARY outcome

Timeframe: RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively

Population: The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria). Only participants with objective response were analyzed.

The DoR (based on RECIST 1.1 as assessed by the Investigator) was defined as the time from the date of first documented response until date of documented progression or death in the absence of PD. The DoR was calculated using Kaplan-Meier technique.

Outcome measures

Outcome measures
Measure
Second Stage: Ovarian Cancer Triplet
n=27 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
n=11 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Small Cell Lung Cancer
n=4 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
n=19 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
n=23 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
n=4 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
n=47 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial and Second Stage Cohorts: Duration of Response (DoR)
11.1 months
Interval 7.4 to 22.1
6.9 months
Interval 5.4 to 11.1
3.6 months
Interval 2.6 to 4.6
9.2 months
Interval 5.5 to 20.3
10.2 months
Interval 5.7 to 22.3
14.8 months
Interval 6.4 to
Upper limit of Inter-quartile range was not reached.
14.8 months
Interval 9.0 to
Upper limit of Inter-quartile range was not reached.

SECONDARY outcome

Timeframe: RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively

Population: The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).

The PFS (based on RECIST 1.1 as assessed by the Investigator) was defined as the time from start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) until the date of objective PD or death (by any cause in the absence of disease progression) regardless of whether the patient withdraws from therapy or receives another anticancer therapy prior to disease progression. The PFS was calculated using Kaplan-Meier technique.

Outcome measures

Outcome measures
Measure
Second Stage: Ovarian Cancer Triplet
n=31 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
n=32 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Small Cell Lung Cancer
n=38 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
n=30 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
n=32 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
n=39 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
n=51 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial and Second Stage Cohorts: Progression-Free Survival (PFS)
14.7 months
Interval 9.2 to 18.1
5.5 months
Interval 3.6 to 7.5
2.4 months
Interval 0.9 to 3.0
8.2 months
Interval 4.6 to 11.8
12.0 months
Interval 8.2 to 15.9
2.6 months
Interval 1.4 to 2.8
15.0 months
Interval 12.9 to 24.1

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 12 and 28. Assessed until DCO 14 Jun 2019

Population: The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria). Only participants with either a tumor size recorded at 12 and 28 weeks or enough information to impute a value were analyzed.

The percentage change in target tumor size at each timepoint (based on RECIST 1.1 target lesion measurements) was obtained for each participant taking the difference between the sum of the target lesions at each timepoint and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline times 100. Baseline was defined as the last evaluable assessment prior to starting olaparib treatment.

Outcome measures

Outcome measures
Measure
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Small Cell Lung Cancer
n=22 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
n=29 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
n=29 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
n=21 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 12 and 28
Week 12
17.23 percentage change in tumor size
Standard Deviation 54.752
-26.13 percentage change in tumor size
Standard Deviation 43.033
-35.86 percentage change in tumor size
Standard Deviation 29.791
20.81 percentage change in tumor size
Standard Deviation 75.944
Initial Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 12 and 28
Week 28
-2.05 percentage change in tumor size
Standard Deviation 15.671
-40.85 percentage change in tumor size
Standard Deviation 39.541
-53.74 percentage change in tumor size
Standard Deviation 31.147
-41.00 percentage change in tumor size
Standard Deviation 43.625

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 24 and 56. Assessed until DCO 17 Sep 2021

Population: The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria). Only participants with either a tumor size recorded at 24 and 56 weeks or enough information to impute a value were analyzed.

The percentage change in target tumor size at each timepoint (based on RECIST 1.1 target lesion measurements) was obtained for each participant taking the difference between the sum of the target lesions at each timepoint and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline times 100. Baseline was defined as the last assessment prior to Cycle 1 Day 1.

Outcome measures

Outcome measures
Measure
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Small Cell Lung Cancer
n=47 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
n=27 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
n=15 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 24 and 56
Week 24
-66.30 percentage change in tumor size
Standard Deviation 26.672
-43.00 percentage change in tumor size
Standard Deviation 32.432
-35.63 percentage change in tumor size
Standard Deviation 34.001
Second Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 24 and 56
Week 56
-77.74 percentage change in tumor size
Standard Deviation 26.472
-60.00 percentage change in tumor size
Standard Deviation 29.058
-39.54 percentage change in tumor size
Standard Deviation 33.719

SECONDARY outcome

Timeframe: From baseline (Day 1) until confirmed PD/death. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively

Population: The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria). Only participants with at least 1 post baseline RECIST target lesion assessment scan were analyzed.

The best percentage change from baseline in target tumor size was based on RECIST 1.1 target lesion measurements taken at each RECIST 1.1 assessment. All measurements until PD or the last evaluable assessment in the absence of PD was included in the calculation. Baseline was defined as the last evaluable assessment prior to starting olaparib treatment for initial stage cohorts. Baseline was defined as the last assessment prior to Cycle 1 Day 1 for second stage cohorts.

Outcome measures

Outcome measures
Measure
Second Stage: Ovarian Cancer Triplet
n=31 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
n=32 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Small Cell Lung Cancer
n=36 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
n=30 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
n=31 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
n=37 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
n=51 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial and Second Stage Cohorts: Best Percentage Change From Baseline in Target Tumor Size
-53.30 percentage change in tumor size
Standard Deviation 33.317
-20.42 percentage change in tumor size
Standard Deviation 41.160
6.27 percentage change in tumor size
Standard Deviation 32.398
-47.60 percentage change in tumor size
Standard Deviation 36.823
-55.55 percentage change in tumor size
Standard Deviation 35.789
1.64 percentage change in tumor size
Standard Deviation 42.338
-72.78 percentage change in tumor size
Standard Deviation 31.497

SECONDARY outcome

Timeframe: From baseline (Day 1) until treatment discontinuation/death. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively

Population: The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).

The TDT was defined as the time from start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) to the earlier of the date of study treatment discontinuation or death. The TDT was calculated using the Kaplan-Meier technique.

Outcome measures

Outcome measures
Measure
Second Stage: Ovarian Cancer Triplet
n=31 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
n=32 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Small Cell Lung Cancer
n=38 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
n=30 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
n=32 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
n=39 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
n=51 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial and Second Stage Cohorts: Time to Study Treatment Discontinuation or Death (TDT)
15.9 months
Interval 10.3 to 18.4
6.6 months
Interval 4.4 to 8.5
2.8 months
Interval 2.0 to 3.8
7.8 months
Interval 6.2 to 12.1
13.1 months
Interval 8.2 to 15.9
2.8 months
Interval 2.1 to 3.2
19.3 months
Interval 14.7 to 26.2

SECONDARY outcome

Timeframe: From baseline (Day 1) until death from any cause. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts

Population: The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).

The OS was defined as the time from the start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) until death due to any cause. The OS was calculated using the Kaplan-Meier technique.

Outcome measures

Outcome measures
Measure
Second Stage: Ovarian Cancer Triplet
n=31 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
n=32 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Small Cell Lung Cancer
n=38 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
n=30 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
n=32 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
n=39 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
n=51 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial and Second Stage Cohorts: OS
31.9 months
Interval 22.1 to
Upper limit of 95% CI had not reached.
26.1 months
Interval 18.7 to
Upper limit of 95% CI had not reached.
7.6 months
Interval 5.6 to 8.8
20.5 months
Interval 16.2 to 25.5
35.5 months
Interval 27.2 to 50.7
6.4 months
Interval 4.3 to 9.1
NA months
Median and 95% CI had not reached.

SECONDARY outcome

Timeframe: Pre-dose and within 10 minutes of end of infusion on Days 1, 85 and 113; Pre-dose on Days 29, 57 and 169; and 90 days post last dose of MEDI4736. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively

Population: The MEDI4736 pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of MEDI4736 and provided evaluable MEDI4736 PK profile for at least 1 treatment period.

Blood samples were collected to determine the serum concentration of MEDI4736.

Outcome measures

Outcome measures
Measure
Second Stage: Ovarian Cancer Triplet
n=31 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
n=32 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Small Cell Lung Cancer
n=36 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
n=34 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
n=32 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
n=36 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
n=51 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial and Second Stage Cohorts: Serum Concentrations of MEDI4736
Day 1: End of infusion
498.8 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 30.27
397.1 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 18.53
483.5 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 35.09
542.5 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 36.04
417.9 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 33.48
391.8 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 25.09
409.3 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 33.27
Initial and Second Stage Cohorts: Serum Concentrations of MEDI4736
Day 29: Pre-dose
96.50 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 34.67
78.23 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 56.60
93.56 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 54.83
Initial and Second Stage Cohorts: Serum Concentrations of MEDI4736
Day 57: Pre-dose
144.7 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 38.96
165.2 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 40.31
171.3 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 31.73
114.7 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 44.78
Initial and Second Stage Cohorts: Serum Concentrations of MEDI4736
Day 85: Pre-dose
145.2 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 55.71
142.8 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 63.07
152.8 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 50.14
Initial and Second Stage Cohorts: Serum Concentrations of MEDI4736
Day 85: End of infusion
589.3 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 35.48
482.9 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 44.01
610.6 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 39.64
Initial and Second Stage Cohorts: Serum Concentrations of MEDI4736
Day 113: Pre-dose
119.5 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 44.27
220.7 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 35.97
231.3 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 33.45
196.9 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 74.60
Initial and Second Stage Cohorts: Serum Concentrations of MEDI4736
Day 113: End of infusion
504.8 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 25.24
671.5 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 31.79
585.5 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 52.67
679.1 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 34.80
Initial and Second Stage Cohorts: Serum Concentrations of MEDI4736
Day 169: Pre-dose
162.6 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 95.86
186.6 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 65.36
133.1 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 30.74
231.5 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 41.14
261.6 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 45.92
230.7 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 35.81
206.3 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 61.24
Initial and Second Stage Cohorts: Serum Concentrations of MEDI4736
90 days post last dose
17.47 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 78.93
20.50 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 340.0
6.907 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 297.9
12.24 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 4720
22.35 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 120.9
17.23 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 155.2
17.94 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 331.8
Initial and Second Stage Cohorts: Serum Concentrations of MEDI4736
Day 1: Pre-dose
NA microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
NA = Below LLOQ. The LLOQ of MEDI4736 is 0.05 mcg/mL.
NA microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
NA = Below LLOQ. The LLOQ of MEDI4736 is 0.05 mcg/mL.
NA microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
NA = Below the lower limit of quantification (LLOQ). The LLOQ of MEDI4736 is 0.05 mcg/mL.
NA microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
NA = Below LLOQ. The LLOQ of MEDI4736 is 0.05 mcg/mL.
NA microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
NA = Below LLOQ. The LLOQ of MEDI4736 is 0.05 mcg/mL.
NA microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
NA = Below LLOQ. The LLOQ of MEDI4736 is 0.05 mcg/mL.
NA microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
NA = Below LLOQ. The LLOQ of MEDI4736 is 0.05 mcg/mL.

SECONDARY outcome

Timeframe: Pre-dose and 0.5-1 hour postdose on Days 1 and 22 of monotherapy; Pre-dose and 0.5-1, 1-3, 3-6 and 6-12 hours postdose on Day 15 of combination therapy. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively

Population: The olaparib PK analysis set included all participants who received at least 1 dose of olaparib and provided evaluable olaparib PK profile for at least 1 treatment period.

Blood samples were collected to determine the serum concentration of olaparib.

Outcome measures

Outcome measures
Measure
Second Stage: Ovarian Cancer Triplet
n=27 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
n=27 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Small Cell Lung Cancer
n=40 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
n=33 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
n=33 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
n=24 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
n=39 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial and Second Stage Cohorts: Serum Concentrations of Olaparib
Monotherapy - Day 1: Pre-dose
NA mcg/mL
Geometric Coefficient of Variation NA
NA = Below LLOQ. The LLOQ of olaparib is 0.0005 mcg/mL.
NA mcg/mL
Geometric Coefficient of Variation NA
NA = Below LLOQ. The LLOQ of olaparib is 0.0005 mcg/mL.
NA mcg/mL
Geometric Coefficient of Variation NA
NA = Below LLOQ. The LLOQ of olaparib is 0.0005 mcg/mL.
NA mcg/mL
Geometric Coefficient of Variation NA
NA = Below LLOQ. The LLOQ of olaparib is 0.0005 mcg/mL.
Initial and Second Stage Cohorts: Serum Concentrations of Olaparib
Monotherapy - Day 1: 0.5-1 hour postdose
3.647 mcg/mL
Geometric Coefficient of Variation 394.2
2.093 mcg/mL
Geometric Coefficient of Variation 1217
5.016 mcg/mL
Geometric Coefficient of Variation 150.1
2.321 mcg/mL
Geometric Coefficient of Variation 291.7
Initial and Second Stage Cohorts: Serum Concentrations of Olaparib
Monotherapy - Day 22: Pre-dose
1.374 mcg/mL
Geometric Coefficient of Variation 814.4
0.8500 mcg/mL
Geometric Coefficient of Variation 1501
1.242 mcg/mL
Geometric Coefficient of Variation 534.6
2.053 mcg/mL
Geometric Coefficient of Variation 124.6
Initial and Second Stage Cohorts: Serum Concentrations of Olaparib
Monotherapy - Day 22: 0.5-1 hour postdose
7.212 mcg/mL
Geometric Coefficient of Variation 55.84
5.370 mcg/mL
Geometric Coefficient of Variation 100.9
6.130 mcg/mL
Geometric Coefficient of Variation 144.9
5.350 mcg/mL
Geometric Coefficient of Variation 75.21
Initial and Second Stage Cohorts: Serum Concentrations of Olaparib
Combination therapy - Day 15: Pre-dose
1.400 mcg/mL
Geometric Coefficient of Variation 423.2
0.9718 mcg/mL
Geometric Coefficient of Variation 663.6
1.848 mcg/mL
Geometric Coefficient of Variation 172.3
0.6526 mcg/mL
Geometric Coefficient of Variation 847.8
1.773 mcg/mL
Geometric Coefficient of Variation 92.68
1.744 mcg/mL
Geometric Coefficient of Variation 103.7
1.544 mcg/mL
Geometric Coefficient of Variation 102.3
Initial and Second Stage Cohorts: Serum Concentrations of Olaparib
Combination therapy - Day 15: 0.5-1 hour postdose
5.922 mcg/mL
Geometric Coefficient of Variation 98.89
6.549 mcg/mL
Geometric Coefficient of Variation 72.47
5.008 mcg/mL
Geometric Coefficient of Variation 74.54
2.805 mcg/mL
Geometric Coefficient of Variation 234.2
4.288 mcg/mL
Geometric Coefficient of Variation 136.4
3.226 mcg/mL
Geometric Coefficient of Variation 60.08
5.439 mcg/mL
Geometric Coefficient of Variation 70.73
Initial and Second Stage Cohorts: Serum Concentrations of Olaparib
Combination therapy - Day 15: 1-3 hour postdose
7.644 mcg/mL
Geometric Coefficient of Variation 55.09
8.038 mcg/mL
Geometric Coefficient of Variation 38.24
4.018 mcg/mL
Geometric Coefficient of Variation 155.6
5.897 mcg/mL
Geometric Coefficient of Variation 90.04
4.804 mcg/mL
Geometric Coefficient of Variation 57.38
Initial and Second Stage Cohorts: Serum Concentrations of Olaparib
Combination therapy - Day 15: 3-6 hour postdose
5.717 mcg/mL
Geometric Coefficient of Variation 57.30
7.811 mcg/mL
Geometric Coefficient of Variation 38.68
5.217 mcg/mL
Geometric Coefficient of Variation 51.57
6.322 mcg/mL
Geometric Coefficient of Variation 43.84
5.491 mcg/mL
Geometric Coefficient of Variation 35.36
Initial and Second Stage Cohorts: Serum Concentrations of Olaparib
Combination therapy - Day 15: 6-12 hour postdose
3.023 mcg/mL
Geometric Coefficient of Variation 74.63
5.186 mcg/mL
Geometric Coefficient of Variation 49.67
2.820 mcg/mL
Geometric Coefficient of Variation 60.56
3.661 mcg/mL
Geometric Coefficient of Variation 57.35
3.679 mcg/mL
Geometric Coefficient of Variation 52.80

SECONDARY outcome

Timeframe: Pre-dose and within 10 minutes of end of infusion on Days 1 and 85; Pre-dose on Days 29 and 169; and 90 days post last dose of bevacizumab. Assessed until DCO 17 Sep 2021

Population: The bevacizumab PK analysis set included all participants who received at least 1 dose of bevacizumab and provided any post-dose evaluable bevacizumab PK concentration.

Blood samples were collected to determine the serum concentration of bevacizumab.

Outcome measures

Outcome measures
Measure
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Small Cell Lung Cancer
n=31 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage Cohort: Serum Concentrations of Bevacizumab
Day 1: Pre-dose
NA mcg/mL
Geometric Coefficient of Variation NA
NA = Below LLOQ. The LLOQ of bevacizumab is 0.5 mcg/mL.
Second Stage Cohort: Serum Concentrations of Bevacizumab
Day 1: End of infusion
243.7 mcg/mL
Geometric Coefficient of Variation 30.01
Second Stage Cohort: Serum Concentrations of Bevacizumab
Day 85: Pre-dose
145.5 mcg/mL
Geometric Coefficient of Variation 28.26
Second Stage Cohort: Serum Concentrations of Bevacizumab
Day 85: End of infusion
364.0 mcg/mL
Geometric Coefficient of Variation 23.74
Second Stage Cohort: Serum Concentrations of Bevacizumab
Day 169: Pre-dose
147.9 mcg/mL
Geometric Coefficient of Variation 118.0
Second Stage Cohort: Serum Concentrations of Bevacizumab
90 days post last dose
5.094 mcg/mL
Geometric Coefficient of Variation 224.1
Second Stage Cohort: Serum Concentrations of Bevacizumab
Day 29: Pre-dose
104.6 mcg/mL
Geometric Coefficient of Variation 29.30

SECONDARY outcome

Timeframe: Pre-dose on Days 1, 15, 57, 85, 113 and 169; and 90 days post-last dose of MEDI4736. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively

Population: The ADA analysis set included all participants in the safety analysis set who have non-missing baseline ADA and at least 1 non-missing post-baseline ADA result for MEDI4736.

Blood samples were measured for the presence of ADAs and ADA-neutralizing antibodies (nAb) for MEDI4736 using validated assays. ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA incidence (treatment-emergent ADA) was defined as the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Treatment-boosted ADA was defined as baseline ADA titer that was boosted to 4-fold or higher following drug administration. Persistently positive was defined as positive at \>=2 post-baseline assessments (with \>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.

Outcome measures

Outcome measures
Measure
Second Stage: Ovarian Cancer Triplet
n=29 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
n=25 Participants
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Small Cell Lung Cancer
n=33 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
n=32 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
n=31 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
n=35 Participants
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial and Second Stage Cohorts: Number of Participants With Anti-Drug Antibody (ADA) Response to MEDI4736
ADA positive post-baseline and positive at baseline
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Initial and Second Stage Cohorts: Number of Participants With Anti-Drug Antibody (ADA) Response to MEDI4736
ADA not detected post-baseline and positive at baseline
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Initial and Second Stage Cohorts: Number of Participants With Anti-Drug Antibody (ADA) Response to MEDI4736
Treatment-boosted ADA
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Initial and Second Stage Cohorts: Number of Participants With Anti-Drug Antibody (ADA) Response to MEDI4736
Persistent positive
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Initial and Second Stage Cohorts: Number of Participants With Anti-Drug Antibody (ADA) Response to MEDI4736
Transient positive
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Initial and Second Stage Cohorts: Number of Participants With Anti-Drug Antibody (ADA) Response to MEDI4736
Any nAb positive among any ADA positive
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Initial and Second Stage Cohorts: Number of Participants With Anti-Drug Antibody (ADA) Response to MEDI4736
ADA prevalence
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Initial and Second Stage Cohorts: Number of Participants With Anti-Drug Antibody (ADA) Response to MEDI4736
ADA incidence
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Initial and Second Stage Cohorts: Number of Participants With Anti-Drug Antibody (ADA) Response to MEDI4736
ADA positive post-baseline and not detected at baseline
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

Adverse Events

Initial Stage: Small Cell Lung Cancer

Serious events: 23 serious events
Other events: 40 other events
Deaths: 36 deaths

Initial Stage: Breast Cancer

Serious events: 4 serious events
Other events: 34 other events
Deaths: 24 deaths

Initial Stage: Ovarian Cancer

Serious events: 10 serious events
Other events: 32 other events
Deaths: 26 deaths

Initial Stage: Gastric Cancer

Serious events: 10 serious events
Other events: 40 other events
Deaths: 35 deaths

Second Stage: Ovarian Cancer Expansion

Serious events: 13 serious events
Other events: 50 other events
Deaths: 13 deaths

Second Stage: Ovarian Cancer Triplet

Serious events: 6 serious events
Other events: 31 other events
Deaths: 17 deaths

Second Stage: Ovarian Cancer Doublet

Serious events: 8 serious events
Other events: 32 other events
Deaths: 20 deaths

Serious adverse events

Serious adverse events
Measure
Initial Stage: Small Cell Lung Cancer
n=40 participants at risk
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
n=34 participants at risk
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
n=34 participants at risk
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
n=40 participants at risk
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
n=51 participants at risk
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Triplet
n=31 participants at risk
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
n=32 participants at risk
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Hepatobiliary disorders
Cholangitis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
General disorders
Asthenia
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Campylobacter gastroenteritis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Lower respiratory tract infection
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Blood and lymphatic system disorders
Pancytopenia
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Blood and lymphatic system disorders
Anaemia
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Renal and urinary disorders
Hydronephrosis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Enterocolitis
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Ileus
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Large intestinal obstruction
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
General disorders
Fatigue
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Intestinal perforation
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Pancreatitis
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Immune system disorders
Anaphylactic reaction
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Pneumonia
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Device related infection
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Cardiac disorders
Acute coronary syndrome
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Pyelonephritis acute
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Hepatobiliary disorders
Hepatic cytolysis
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Injury, poisoning and procedural complications
Fibula fracture
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Cardiac disorders
Atrial fibrillation
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Cardiac disorders
Atrial tachycardia
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Infection
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Nervous system disorders
Encephalitis autoimmune
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Nervous system disorders
Ischaemic stroke
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Cardiac disorders
Tachycardia
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Renal and urinary disorders
Ureterolithiasis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Blood and lymphatic system disorders
Febrile bone marrow aplasia
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Blood and lymphatic system disorders
Febrile neutropenia
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Blood and lymphatic system disorders
Haemolysis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Dysphagia
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Gastric haemorrhage
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Vomiting
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Intestinal obstruction
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Nausea
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Melaena
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
General disorders
General physical health deterioration
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
General disorders
Malaise
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
General disorders
Multiple organ dysfunction syndrome
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
General disorders
Pyrexia
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Immune system disorders
Cytokine release syndrome
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Atypical pneumonia
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Bacterial infection
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Diverticulitis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Gastroenteritis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Herpes zoster
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Lower respiratory tract infection viral
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Pneumocystis jirovecii pneumonia
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Postoperative wound infection
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Cardiac disorders
Cardiac failure
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Pyelonephritis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Sepsis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Septic shock
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Cardiac disorders
Cardiac failure congestive
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Streptococcal infection
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Urinary tract infection
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Urosepsis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Cardiac disorders
Myocardial infarction
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Injury, poisoning and procedural complications
Fall
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Injury, poisoning and procedural complications
Incisional hernia
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Cardiac disorders
Pericardial effusion
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Injury, poisoning and procedural complications
Spinal compression fracture
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
Blood testosterone decreased
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Endocrine disorders
Adrenal insufficiency
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Renal and urinary disorders
Acute kidney injury
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Renal and urinary disorders
Renal impairment
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Skin and subcutaneous tissue disorders
Dermatitis allergic
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Vascular disorders
Hypotension
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Vascular disorders
Lymphoedema
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Abdominal pain
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Constipation
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.

Other adverse events

Other adverse events
Measure
Initial Stage: Small Cell Lung Cancer
n=40 participants at risk
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Breast Cancer
n=34 participants at risk
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Ovarian Cancer
n=34 participants at risk
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Initial Stage: Gastric Cancer
n=40 participants at risk
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Expansion
n=51 participants at risk
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Triplet
n=31 participants at risk
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Second Stage: Ovarian Cancer Doublet
n=32 participants at risk
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
General disorders
Non-cardiac chest pain
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Gastroenteritis viral
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Blood and lymphatic system disorders
Anaemia
72.5%
29/40 • Number of events 33 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
41.2%
14/34 • Number of events 28 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
55.9%
19/34 • Number of events 55 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
37.5%
15/40 • Number of events 18 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
49.0%
25/51 • Number of events 39 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
58.1%
18/31 • Number of events 41 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
40.6%
13/32 • Number of events 20 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Influenza
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Nasopharyngitis
10.0%
4/40 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.9%
4/31 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Oral candidiasis
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
7.5%
3/40 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Oral herpes
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.7%
3/31 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Pneumonia
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Sinusitis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Urinary tract infection
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
4/34 • Number of events 9 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
15.7%
8/51 • Number of events 14 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
29.0%
9/31 • Number of events 12 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
15.6%
5/32 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
Lipase increased
12.5%
5/40 • Number of events 7 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
14.7%
5/34 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.5%
5/40 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.7%
3/31 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Injury, poisoning and procedural complications
Fall
2.5%
1/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Injury, poisoning and procedural complications
Tooth fracture
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
Alanine aminotransferase increased
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
4/34 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.8%
5/51 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
16.1%
5/31 • Number of events 10 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
Blood alkaline phosphatase increased
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
3/51 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
Blood creatine increased
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Metabolism and nutrition disorders
Hypokalaemia
10.0%
4/40 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
4/34 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
3/51 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Musculoskeletal and connective tissue disorders
Joint swelling
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.9%
4/31 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Ear and labyrinth disorders
Vertigo
2.5%
1/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Endocrine disorders
Hypothyroidism
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
14.7%
5/34 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
17.6%
6/34 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
19.6%
10/51 • Number of events 11 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
15.6%
5/32 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Eye disorders
Vision blurred
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
3/51 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.5%
4/32 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Constipation
35.0%
14/40 • Number of events 15 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
29.4%
10/34 • Number of events 13 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
32.4%
11/34 • Number of events 14 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
40.0%
16/40 • Number of events 22 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
41.2%
21/51 • Number of events 23 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
25.8%
8/31 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
25.0%
8/32 • Number of events 9 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Gingival bleeding
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Blood and lymphatic system disorders
Lymphopenia
12.5%
5/40 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
General disorders
Influenza like illness
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
14.7%
5/34 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
20.6%
7/34 • Number of events 7 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
3/51 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.9%
4/31 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Haemorrhoids
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Mouth ulceration
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Nausea
45.0%
18/40 • Number of events 26 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
58.8%
20/34 • Number of events 27 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
76.5%
26/34 • Number of events 56 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
50.0%
20/40 • Number of events 24 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
66.7%
34/51 • Number of events 51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
74.2%
23/31 • Number of events 44 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
87.5%
28/32 • Number of events 46 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Stomatitis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
14.7%
5/34 • Number of events 13 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
15.7%
8/51 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
22.6%
7/31 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Toothache
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.9%
4/31 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Vomiting
30.0%
12/40 • Number of events 18 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
32.4%
11/34 • Number of events 12 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
41.2%
14/34 • Number of events 39 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
42.5%
17/40 • Number of events 28 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
39.2%
20/51 • Number of events 37 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
51.6%
16/31 • Number of events 27 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.5%
4/32 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
General disorders
Asthenia
17.5%
7/40 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
23.5%
8/34 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.5%
5/40 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
6/51 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
21.9%
7/32 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
General disorders
Early satiety
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
General disorders
Fatigue
40.0%
16/40 • Number of events 18 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
64.7%
22/34 • Number of events 29 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
58.8%
20/34 • Number of events 28 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
27.5%
11/40 • Number of events 11 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
54.9%
28/51 • Number of events 36 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
51.6%
16/31 • Number of events 25 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
50.0%
16/32 • Number of events 22 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Blood and lymphatic system disorders
Neutropenia
5.0%
2/40 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
14.7%
5/34 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
7.8%
4/51 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.7%
3/31 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.5%
4/32 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
General disorders
Malaise
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
3/51 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.2%
2/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
General disorders
Mucosal inflammation
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
3/51 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
General disorders
Oedema peripheral
15.0%
6/40 • Number of events 7 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
4/34 • Number of events 7 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.5%
5/40 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.7%
3/31 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.5%
4/32 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
General disorders
Pain
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
General disorders
Pyrexia
15.0%
6/40 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
3/51 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Blood and lymphatic system disorders
Thrombocytopenia
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Bronchitis
10.0%
4/40 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Cystitis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
3/51 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Gingivitis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Lower respiratory tract infection
10.0%
4/40 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
3/51 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Rhinitis
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.7%
3/31 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Upper respiratory tract infection
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
14.7%
5/34 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
6/51 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Vaginal infection
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Infections and infestations
Viral upper respiratory tract infection
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.2%
2/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Cardiac disorders
Palpitations
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
7.8%
4/51 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.4%
3/32 • Number of events 7 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
Amylase increased
10.0%
4/40 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
14.7%
5/34 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
Aspartate aminotransferase increased
10.0%
4/40 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
15.7%
8/51 • Number of events 15 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
22.6%
7/31 • Number of events 12 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
Blood creatinine increased
20.0%
8/40 • Number of events 10 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
6/51 • Number of events 10 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
16.1%
5/31 • Number of events 11 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
21.9%
7/32 • Number of events 11 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
Blood lactate dehydrogenase increased
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
Blood potassium increased
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
Blood thyroid stimulating hormone increased
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.7%
3/31 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.2%
2/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
Gamma-glutamyltransferase increased
10.0%
4/40 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
Lymphocyte count decreased
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
4/34 • Number of events 16 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.7%
3/31 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
Neutrophil count decreased
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
4/34 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
3/51 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.7%
3/31 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.5%
4/32 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
Platelet count decreased
12.5%
5/40 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 27 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.9%
4/31 • Number of events 7 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
Thyroid function test abnormal
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
Weight decreased
15.0%
6/40 • Number of events 7 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
23.5%
8/34 • Number of events 9 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
35.0%
14/40 • Number of events 16 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
23.5%
12/51 • Number of events 14 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
22.6%
7/31 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
Weight increased
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Investigations
White blood cell count decreased
12.5%
5/40 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
17.6%
6/34 • Number of events 21 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
4/34 • Number of events 9 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
7.8%
4/51 • Number of events 9 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.9%
4/31 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.2%
2/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Metabolism and nutrition disorders
Decreased appetite
35.0%
14/40 • Number of events 17 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
14.7%
5/34 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
29.4%
10/34 • Number of events 15 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
37.5%
15/40 • Number of events 15 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
19.6%
10/51 • Number of events 12 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
38.7%
12/31 • Number of events 19 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
28.1%
9/32 • Number of events 13 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Metabolism and nutrition disorders
Hyperglycaemia
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Metabolism and nutrition disorders
Hypocalcaemia
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Metabolism and nutrition disorders
Hypomagnesaemia
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
14.7%
5/34 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Metabolism and nutrition disorders
Hyponatraemia
12.5%
5/40 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Musculoskeletal and connective tissue disorders
Arthralgia
10.0%
4/40 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
20.6%
7/34 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
29.4%
10/34 • Number of events 12 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
6/51 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
29.0%
9/31 • Number of events 11 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
25.0%
8/32 • Number of events 11 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Musculoskeletal and connective tissue disorders
Back pain
15.0%
6/40 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
20.6%
7/34 • Number of events 12 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
15.7%
8/51 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
16.1%
5/31 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
21.9%
7/32 • Number of events 7 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Musculoskeletal and connective tissue disorders
Flank pain
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.8%
5/51 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Musculoskeletal and connective tissue disorders
Muscle spasms
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.8%
5/51 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.7%
3/31 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
10.0%
4/40 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Musculoskeletal and connective tissue disorders
Myalgia
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
17.6%
6/34 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
14.7%
5/34 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
10.0%
4/40 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
7.8%
4/51 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
16.1%
5/31 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
21.9%
7/32 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Musculoskeletal and connective tissue disorders
Neck pain
10.0%
4/40 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Musculoskeletal and connective tissue disorders
Pain in extremity
7.5%
3/40 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
4/34 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
6/51 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.7%
3/31 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.5%
4/32 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Nervous system disorders
Disturbance in attention
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Nervous system disorders
Dizziness
12.5%
5/40 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
14.7%
5/34 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
15.0%
6/40 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
17.6%
9/51 • Number of events 12 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.7%
3/31 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Nervous system disorders
Dysgeusia
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
23.5%
8/34 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
14.7%
5/34 • Number of events 7 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
13.7%
7/51 • Number of events 7 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.9%
4/31 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
18.8%
6/32 • Number of events 7 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Nervous system disorders
Headache
22.5%
9/40 • Number of events 10 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
20.6%
7/34 • Number of events 11 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
17.6%
6/34 • Number of events 10 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
10.0%
4/40 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
15.7%
8/51 • Number of events 11 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
35.5%
11/31 • Number of events 22 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
21.9%
7/32 • Number of events 9 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Nervous system disorders
Hypoaesthesia
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Nervous system disorders
Lethargy
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 7 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
7.5%
3/40 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.7%
3/31 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Nervous system disorders
Neuralgia
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Nervous system disorders
Neuropathy peripheral
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Nervous system disorders
Paraesthesia
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Nervous system disorders
Taste disorder
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
7.8%
4/51 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.7%
3/31 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Nervous system disorders
Tremor
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Psychiatric disorders
Anxiety
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
17.6%
6/34 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
4/34 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
7.8%
4/51 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.7%
3/31 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Psychiatric disorders
Depression
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
7.8%
4/51 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.4%
3/32 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Psychiatric disorders
Insomnia
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
14.7%
5/34 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
4/34 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
15.7%
8/51 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.9%
4/31 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
15.6%
5/32 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Renal and urinary disorders
Acute kidney injury
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Endocrine disorders
Hyperthyroidism
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Renal and urinary disorders
Chronic kidney disease
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Renal and urinary disorders
Dysuria
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
3/51 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.7%
3/31 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Renal and urinary disorders
Pollakiuria
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Renal and urinary disorders
Proteinuria
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
29.0%
9/31 • Number of events 11 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Renal and urinary disorders
Renal pain
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Renal and urinary disorders
Urinary tract pain
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Eye disorders
Diplopia
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Renal and urinary disorders
Urine odour abnormal
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Reproductive system and breast disorders
Pelvic pain
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Respiratory, thoracic and mediastinal disorders
Cough
30.0%
12/40 • Number of events 12 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
29.4%
10/34 • Number of events 15 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
14.7%
5/34 • Number of events 9 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.5%
5/40 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
21.6%
11/51 • Number of events 15 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
16.1%
5/31 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.4%
3/32 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Respiratory, thoracic and mediastinal disorders
Dysphonia
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
16.1%
5/31 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
30.0%
12/40 • Number of events 13 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
32.4%
11/34 • Number of events 18 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
25.5%
13/51 • Number of events 18 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.9%
4/31 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.5%
4/32 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
22.6%
7/31 • Number of events 9 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
12.5%
5/40 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Respiratory, thoracic and mediastinal disorders
Productive cough
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
3/51 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.8%
5/51 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.7%
3/31 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Skin and subcutaneous tissue disorders
Dermatitis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Skin and subcutaneous tissue disorders
Dry skin
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
14.7%
5/34 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
29.4%
10/34 • Number of events 11 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
3/51 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
16.1%
5/31 • Number of events 7 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Skin and subcutaneous tissue disorders
Erythema
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
4/34 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Skin and subcutaneous tissue disorders
Petechiae
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Skin and subcutaneous tissue disorders
Pruritus
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
17.6%
6/34 • Number of events 7 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
7.5%
3/40 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
6/51 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.7%
3/31 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
15.6%
5/32 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Skin and subcutaneous tissue disorders
Rash
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
26.5%
9/34 • Number of events 16 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
15.0%
6/40 • Number of events 9 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
13.7%
7/51 • Number of events 11 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
22.6%
7/31 • Number of events 10 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.8%
5/51 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Eye disorders
Dry eye
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
3/51 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Vascular disorders
Flushing
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Vascular disorders
Hot flush
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
4/34 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.0%
1/51 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Vascular disorders
Hypertension
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
7.8%
4/51 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
25.8%
8/31 • Number of events 19 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.2%
2/32 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Vascular disorders
Hypotension
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Abdominal discomfort
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
3/51 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Abdominal distension
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
20.6%
7/34 • Number of events 8 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.5%
1/40 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.9%
4/31 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Abdominal pain
7.5%
3/40 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
17.6%
6/34 • Number of events 10 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
17.6%
6/34 • Number of events 9 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
20.0%
8/40 • Number of events 9 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
29.4%
15/51 • Number of events 19 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
25.8%
8/31 • Number of events 10 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
18.8%
6/32 • Number of events 9 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Abdominal pain upper
22.5%
9/40 • Number of events 12 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
4/34 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
3/51 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Ascites
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
4/34 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Colitis
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
3/51 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Diarrhoea
22.5%
9/40 • Number of events 11 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
35.3%
12/34 • Number of events 14 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
35.3%
12/34 • Number of events 20 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
27.5%
11/40 • Number of events 16 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
33.3%
17/51 • Number of events 28 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
38.7%
12/31 • Number of events 27 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
43.8%
14/32 • Number of events 21 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Dry mouth
2.5%
1/40 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.8%
5/51 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.4%
3/32 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Dyspepsia
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
8.8%
3/34 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
17.5%
7/40 • Number of events 7 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.8%
5/51 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
19.4%
6/31 • Number of events 6 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
12.5%
4/32 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Dysphagia
7.5%
3/40 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
10.0%
4/40 • Number of events 5 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.9%
2/51 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/31 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/32 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Flatulence
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/34 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
2.9%
1/34 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/40 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
0.00%
0/51 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
3.2%
1/31 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
Gastrointestinal disorders
Gastrooesophageal reflux disease
5.0%
2/40 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
2/34 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
11.8%
4/34 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
10.0%
4/40 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
5.9%
3/51 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
6.5%
2/31 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
The safety analysis set included all participants who received at least 1 dose of study treatment. For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Results disclosure agreements

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