Trial Outcomes & Findings for M6620 Plus Standard Treatment in Oesophageal and Other Cancer (NCT NCT03641547)

NCT ID: NCT03641547

Last Updated: 2024-07-18

Results Overview

To determine the best tolerated M6620 (Berzosertib) treatment schedule (or phase II recommended dose, RPTD) administered concomitantly with radiotherapy (RT) only in the palliative treatment of oesophageal cancer.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 36 participants
• Primary outcome timeframe: From start of M6620 (Berzosertib) treatment to 6-week follow up visit (9 weeks)
• Results posted on: 2024-07-18

Participant Flow

Participant milestones

Measure	A1 - Dose Level 1 Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 9, 16.	A1 - Dose Level 2 Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 3 Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16, 19.	A1 - Dose Level 4 Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 9, 16.	A1 - Dose Level 5 Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 6 Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16, 19.	A2 - Dose Level 1 Cisplatin/capecitabine + M6620 (Berzosertib) administered at 90 mg/m2 once a week for 18 weeks.	A2 - Dose Level 2 Cisplatin/capecitabine + M6620 (Berzosertib) administered at 90 mg/m2 twice a week for 18 weeks.	A2 - Dose Level 3 Cisplatin/capecitabine + M6620 (Berzosertib) administered at 140 mg/m2 once a week for 18 weeks.	A2 - Dose Level 4 Cisplatin/capecitabine + M6620 (Berzosertib) administered at 140 mg/m2 twice a week for 18 weeks.
Overall Study STARTED	3	1	1	1	1	9	5	1	9	5
Overall Study COMPLETED	3	1	1	1	1	9	2	1	4	3
Overall Study NOT COMPLETED	0	0	0	0	0	0	3	0	5	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

M6620 Plus Standard Treatment in Oesophageal and Other Cancer

Baseline characteristics by cohort

Measure	A1 - Dose Level 1 n=3 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 9, 16.	A1 - Dose Level 2 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 3 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16, 19.	A1 - Dose Level 4 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 9, 16.	A1 - Dose Level 5 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 6 n=9 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16, 19.	A2 - Dose Level 1 n=5 Participants Cisplatin/capecitabine + M6620 (Berzosertib) administered at 90 mg/m2 once a week for 18 weeks.	A2 - Dose Level 2 n=1 Participants Cisplatin/capecitabine + M6620 (Berzosertib) administered at 90 mg/m2 twice a week for 18 weeks.	A2 - Dose Level 3 n=9 Participants Cisplatin/capecitabine + M6620 (Berzosertib) administered at 140 mg/m2 once a week for 18 weeks.	A2 - Dose Level 4 n=5 Participants Cisplatin/capecitabine + M6620 (Berzosertib) administered at 140 mg/m2 twice a week for 18 weeks.	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=10 Participants	2 Participants n=115 Participants	1 Participants n=6 Participants	3 Participants n=6 Participants	3 Participants n=64 Participants	17 Participants n=17 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=10 Participants	3 Participants n=115 Participants	0 Participants n=6 Participants	6 Participants n=6 Participants	2 Participants n=64 Participants	19 Participants n=17 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	0 Participants n=6 Participants	6 Participants n=6 Participants	3 Participants n=64 Participants	13 Participants n=17 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	8 Participants n=10 Participants	3 Participants n=115 Participants	1 Participants n=6 Participants	3 Participants n=6 Participants	2 Participants n=64 Participants	23 Participants n=17 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	9 Participants n=10 Participants	5 Participants n=115 Participants	1 Participants n=6 Participants	9 Participants n=6 Participants	5 Participants n=64 Participants	36 Participants n=17 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants
Smoking status Ex-smoker	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	6 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 Participants	4 Participants n=6 Participants	3 Participants n=64 Participants	20 Participants n=17 Participants
Smoking status Never smoked	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants	3 Participants n=115 Participants	0 Participants n=6 Participants	5 Participants n=6 Participants	2 Participants n=64 Participants	15 Participants n=17 Participants
Smoking status Current smoker	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	1 Participants n=17 Participants
Locoregional Disease Yes	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	6 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	6 Participants n=6 Participants	3 Participants n=64 Participants	23 Participants n=17 Participants
Locoregional Disease No	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants	4 Participants n=115 Participants	1 Participants n=6 Participants	3 Participants n=6 Participants	2 Participants n=64 Participants	13 Participants n=17 Participants
Distant Metastases Yes	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=10 Participants	5 Participants n=115 Participants	1 Participants n=6 Participants	8 Participants n=6 Participants	5 Participants n=64 Participants	25 Participants n=17 Participants
Distant Metastases No	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=64 Participants	11 Participants n=17 Participants
Prior Radiotherapy Yes	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	4 Participants n=115 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants	2 Participants n=64 Participants	9 Participants n=17 Participants
Prior Radiotherapy No	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	8 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 Participants	7 Participants n=6 Participants	3 Participants n=64 Participants	27 Participants n=17 Participants
Prior Systemic Treatment Yes	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	8 Participants n=10 Participants	4 Participants n=115 Participants	1 Participants n=6 Participants	9 Participants n=6 Participants	5 Participants n=64 Participants	32 Participants n=17 Participants
Prior Systemic Treatment No	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	4 Participants n=17 Participants
Tumour grade Well differentiated (G1)	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=64 Participants	2 Participants n=17 Participants
Tumour grade Moderately differentiated (G2)	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 Participants	3 Participants n=6 Participants	0 Participants n=64 Participants	8 Participants n=17 Participants
Tumour grade Poorly differentiated (G3)	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=10 Participants	4 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	3 Participants n=64 Participants	15 Participants n=17 Participants
Tumour grade Unknown or cannot be assessed (GX)	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	5 Participants n=6 Participants	2 Participants n=64 Participants	11 Participants n=17 Participants

PRIMARY outcome

Timeframe: From start of M6620 (Berzosertib) treatment to 6-week follow up visit (9 weeks)

To determine the best tolerated M6620 (Berzosertib) treatment schedule (or phase II recommended dose, RPTD) administered concomitantly with radiotherapy (RT) only in the palliative treatment of oesophageal cancer.

Outcome measures

Measure	A1 - Dose Level 1 n=3 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 9, 16.	A1 - Dose Level 2 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 3 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16, 19.	A1 - Dose Level 4 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 9, 16.	A1 - Dose Level 5 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 6 n=9 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16, 19.
STAGE A1 - Number of Dose Limiting Toxicities for M6620 (Berzosertib) Administered Concomitantly With Radiotherapy (RT) in the Palliative Treatment of Oesophageal Cancer.	0 Dose Limiting Toxicities (DLTs)	0 Dose Limiting Toxicities (DLTs)	0 Dose Limiting Toxicities (DLTs)	0 Dose Limiting Toxicities (DLTs)	0 Dose Limiting Toxicities (DLTs)	0 Dose Limiting Toxicities (DLTs)

PRIMARY outcome

Timeframe: From start of M6620 (Berzosertib) treatment to end of first week of cycle two of chemotherapy (4 weeks)

To determine the best tolerated M6620 (Berzosertib) treatment schedule (or phase II recommended dose, RPTD) administered concomitantly with chemotherapy (cisplatin and capecitabine) only in the palliative treatment of solid cancer.

Outcome measures

Measure	A1 - Dose Level 1 n=4 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 9, 16.	A1 - Dose Level 2 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 3 n=9 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16, 19.	A1 - Dose Level 4 n=4 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 9, 16.	A1 - Dose Level 5 Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 6 Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16, 19.
STAGE A2 - Number of Dose Limiting Toxicities for M6620 (Berzosertib) Administered Concomitantly With Chemotherapy (Cisplatin and Capecitabine) in the Palliative Treatment of Solid Cancer.	0 Dose Limiting Toxicities (DLTs)	0 Dose Limiting Toxicities (DLTs)	2 Dose Limiting Toxicities (DLTs)	0 Dose Limiting Toxicities (DLTs)	—	—

PRIMARY outcome

Timeframe: 24 weeks

Population: Due to lack of funding, Stage B was not completed.

Highest treatment schedule resulting in less than 45% dose limiting toxicity (DLT) rate.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of M6620 (Berzosertib) treatment to 9-week follow up visit (12 weeks)

Toxicity profile when M6620 is administered concomitantly with RT in the palliative treatment of oesophageal cancer. Worst grade adverse event for each patient by dose schedule (according to the Common Terminology Criteria for Adverse Events, Version 4.03). Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe or medically significant, but not immediately life-threatening); Grade 4 (life-threatening); Grade 5 (death).

Outcome measures

Measure	A1 - Dose Level 1 n=3 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 9, 16.	A1 - Dose Level 2 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 3 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16, 19.	A1 - Dose Level 4 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 9, 16.	A1 - Dose Level 5 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 6 n=9 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16, 19.
STAGE A1 - Severity of Worst Adverse Events for M6620 (Berzosertib) Administered Concomitantly With Radiotherapy (RT) in the Palliative Treatment of Oesophageal Cancer. Worst AE: Grade 1	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	2 Participants
STAGE A1 - Severity of Worst Adverse Events for M6620 (Berzosertib) Administered Concomitantly With Radiotherapy (RT) in the Palliative Treatment of Oesophageal Cancer. Worst AE: Grade 2	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
STAGE A1 - Severity of Worst Adverse Events for M6620 (Berzosertib) Administered Concomitantly With Radiotherapy (RT) in the Palliative Treatment of Oesophageal Cancer. Worst AE: Grade 3	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	6 Participants
STAGE A1 - Severity of Worst Adverse Events for M6620 (Berzosertib) Administered Concomitantly With Radiotherapy (RT) in the Palliative Treatment of Oesophageal Cancer. Worst AE: Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From start of M6620 (Berzosertib) treatment to last dose (3 weeks)

Treatment compliance of M6620 (Berzosertib) and palliative radiotherapy when taken concomitantly.

Outcome measures

Measure	A1 - Dose Level 1 n=3 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 9, 16.	A1 - Dose Level 2 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 3 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16, 19.	A1 - Dose Level 4 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 9, 16.	A1 - Dose Level 5 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 6 n=9 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16, 19.
STAGE A1 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Palliative Radiotherapy M6620 (Berzosertib) compliance · <75%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
STAGE A1 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Palliative Radiotherapy Radiotherapy compliance · 100%	3 Participants	1 Participants	1 Participants	1 Participants	1 Participants	7 Participants
STAGE A1 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Palliative Radiotherapy Radiotherapy compliance · >=90%, <100%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
STAGE A1 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Palliative Radiotherapy Radiotherapy compliance · >=75%,<90%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
STAGE A1 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Palliative Radiotherapy Radiotherapy compliance · <75%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
STAGE A1 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Palliative Radiotherapy M6620 (Berzosertib) compliance · 100%	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants	5 Participants
STAGE A1 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Palliative Radiotherapy M6620 (Berzosertib) compliance · >=90%, <100%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
STAGE A1 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Palliative Radiotherapy M6620 (Berzosertib) compliance · >=75%,<90%	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: At 12 weeks following start of M6620 (Berzosertib) treatment

Population: Overall RECIST at 12 Weeks

Efficacy of the combination (M6620 and radiotherapy), measured by objective tumour response via RECIST 1.1 (Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-247. doi:10.1016/j.ejca.2008.10.026). From Progressive Disease (PD) to Complete Response (CR).

Outcome measures

Measure	A1 - Dose Level 1 n=3 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 9, 16.	A1 - Dose Level 2 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 3 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16, 19.	A1 - Dose Level 4 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 9, 16.	A1 - Dose Level 5 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 6 n=9 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16, 19.
STAGE A1 - Objective Tumour Response to M6620 (Berzosertib) Plus Radiotherapy, as Evaluated by CT Scan and Quantified by RECIST 1.1. Complete Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
STAGE A1 - Objective Tumour Response to M6620 (Berzosertib) Plus Radiotherapy, as Evaluated by CT Scan and Quantified by RECIST 1.1. Partial Response	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
STAGE A1 - Objective Tumour Response to M6620 (Berzosertib) Plus Radiotherapy, as Evaluated by CT Scan and Quantified by RECIST 1.1. Stable Disease	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	2 Participants
STAGE A1 - Objective Tumour Response to M6620 (Berzosertib) Plus Radiotherapy, as Evaluated by CT Scan and Quantified by RECIST 1.1. Progressive Disease	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants
STAGE A1 - Objective Tumour Response to M6620 (Berzosertib) Plus Radiotherapy, as Evaluated by CT Scan and Quantified by RECIST 1.1. Not Evaluable	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
STAGE A1 - Objective Tumour Response to M6620 (Berzosertib) Plus Radiotherapy, as Evaluated by CT Scan and Quantified by RECIST 1.1. Missing Data	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: From start of M6620 (Berzosertib) treatment to 8-week post-end of treatment follow up visit (26 weeks)

Population: 2 participants were not included in this analysis as they did not take any IMP.

Toxicity profile when M6620 is administered concomitantly with chemotherapy in the treatment of oesophageal cancer. Worst grade adverse event for each patient by dose schedule (according to the Common Terminology Criteria for Adverse Events, Version 4.03). Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe or medically significant, but not immediately life-threatening); Grade 4 (life-threatening); Grade 5 (death).

Outcome measures

Measure	A1 - Dose Level 1 n=4 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 9, 16.	A1 - Dose Level 2 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 3 n=9 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16, 19.	A1 - Dose Level 4 n=4 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 9, 16.	A1 - Dose Level 5 Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 6 Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16, 19.
STAGE A2 - Severity of Worst Adverse Events for M6620 (Berzosertib) Administered Concomitantly With Chemotherapy (Cisplatin and Capecitabine) in the Palliative Treatment of Solid Cancer Worst AE: Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	—	—
STAGE A2 - Severity of Worst Adverse Events for M6620 (Berzosertib) Administered Concomitantly With Chemotherapy (Cisplatin and Capecitabine) in the Palliative Treatment of Solid Cancer Worst AE: Grade 2	2 Participants	1 Participants	2 Participants	1 Participants	—	—
STAGE A2 - Severity of Worst Adverse Events for M6620 (Berzosertib) Administered Concomitantly With Chemotherapy (Cisplatin and Capecitabine) in the Palliative Treatment of Solid Cancer Worst AE: Grade 3	1 Participants	0 Participants	6 Participants	2 Participants	—	—
STAGE A2 - Severity of Worst Adverse Events for M6620 (Berzosertib) Administered Concomitantly With Chemotherapy (Cisplatin and Capecitabine) in the Palliative Treatment of Solid Cancer Worst AE: Grade 4	1 Participants	0 Participants	1 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: From start of M6620 (Berzosertib) treatment to last dose (18 weeks)

Population: 2 participants were not included in this analysis as they did not take any IMP.

Treatment compliance of M6620 (Berzosertib), capecitabine and cisplatin when taken concomitantly.

Outcome measures

Measure	A1 - Dose Level 1 n=4 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 9, 16.	A1 - Dose Level 2 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 3 n=9 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16, 19.	A1 - Dose Level 4 n=4 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 9, 16.	A1 - Dose Level 5 Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 6 Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16, 19.
STAGE A2 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Chemotherapy (Cisplatin and Capecitabine) in the Palliative Treatment of Solid Cancer. Cisplatin compliance · >=75%, <90%	0 Participants	1 Participants	0 Participants	0 Participants	—	—
STAGE A2 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Chemotherapy (Cisplatin and Capecitabine) in the Palliative Treatment of Solid Cancer. M6620 (Berzosertib) compliance in cycle 1 · <75%	1 Participants	0 Participants	5 Participants	2 Participants	—	—
STAGE A2 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Chemotherapy (Cisplatin and Capecitabine) in the Palliative Treatment of Solid Cancer. Capecitabine compliance · 100%	0 Participants	0 Participants	1 Participants	0 Participants	—	—
STAGE A2 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Chemotherapy (Cisplatin and Capecitabine) in the Palliative Treatment of Solid Cancer. Capecitabine compliance · >=90%, <100%	1 Participants	0 Participants	0 Participants	0 Participants	—	—
STAGE A2 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Chemotherapy (Cisplatin and Capecitabine) in the Palliative Treatment of Solid Cancer. Capecitabine compliance · >=75%, <90%	0 Participants	1 Participants	0 Participants	0 Participants	—	—
STAGE A2 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Chemotherapy (Cisplatin and Capecitabine) in the Palliative Treatment of Solid Cancer. Capecitabine compliance · <75%	3 Participants	0 Participants	8 Participants	4 Participants	—	—
STAGE A2 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Chemotherapy (Cisplatin and Capecitabine) in the Palliative Treatment of Solid Cancer. Cisplatin compliance · 100%	1 Participants	0 Participants	2 Participants	0 Participants	—	—
STAGE A2 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Chemotherapy (Cisplatin and Capecitabine) in the Palliative Treatment of Solid Cancer. Cisplatin compliance · >=90%, <100%	0 Participants	0 Participants	1 Participants	0 Participants	—	—
STAGE A2 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Chemotherapy (Cisplatin and Capecitabine) in the Palliative Treatment of Solid Cancer. Cisplatin compliance · <75%	3 Participants	0 Participants	6 Participants	4 Participants	—	—
STAGE A2 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Chemotherapy (Cisplatin and Capecitabine) in the Palliative Treatment of Solid Cancer. M6620 (Berzosertib) compliance in cycle 1 · 100%	3 Participants	0 Participants	4 Participants	2 Participants	—	—
STAGE A2 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Chemotherapy (Cisplatin and Capecitabine) in the Palliative Treatment of Solid Cancer. M6620 (Berzosertib) compliance in cycle 1 · >=90%, <100%	0 Participants	0 Participants	0 Participants	0 Participants	—	—
STAGE A2 - Number of Patients Completing at Least 75%, 90% and 100% of the Planned Treatment Dose of M6620 (Berzosertib) in Combination With Chemotherapy (Cisplatin and Capecitabine) in the Palliative Treatment of Solid Cancer. M6620 (Berzosertib) compliance in cycle 1 · >=75%, <90%	0 Participants	1 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: At 12 weeks following start of M6620 (Berzosertib) treatment

Population: Overall RECIST at 12 Weeks

Efficacy of the combination (M6620 and chemotherapy), measured by objective tumour response via RECIST 1.1 (Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-247. doi:10.1016/j.ejca.2008.10.026). From Progressive Disease (PD) to Complete Response (CR).

Outcome measures

Measure	A1 - Dose Level 1 n=5 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 9, 16.	A1 - Dose Level 2 n=1 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 3 n=9 Participants Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16, 19.	A1 - Dose Level 4 n=5 Participants Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 9, 16.	A1 - Dose Level 5 Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 6 Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16, 19.
STAGE A2 - Objective Tumour Response to M6620 (Berzosertib) Plus Chemotherapy, as Evaluated by CT Scan and Quantified by RECIST 1.1. Complete Response	0 Participants	0 Participants	0 Participants	0 Participants	—	—
STAGE A2 - Objective Tumour Response to M6620 (Berzosertib) Plus Chemotherapy, as Evaluated by CT Scan and Quantified by RECIST 1.1. Partial Response	1 Participants	1 Participants	0 Participants	1 Participants	—	—
STAGE A2 - Objective Tumour Response to M6620 (Berzosertib) Plus Chemotherapy, as Evaluated by CT Scan and Quantified by RECIST 1.1. Stable Disease	0 Participants	0 Participants	2 Participants	2 Participants	—	—
STAGE A2 - Objective Tumour Response to M6620 (Berzosertib) Plus Chemotherapy, as Evaluated by CT Scan and Quantified by RECIST 1.1. Progressive Disease	0 Participants	0 Participants	1 Participants	0 Participants	—	—
STAGE A2 - Objective Tumour Response to M6620 (Berzosertib) Plus Chemotherapy, as Evaluated by CT Scan and Quantified by RECIST 1.1. Not Evaluable	0 Participants	0 Participants	0 Participants	0 Participants	—	—
STAGE A2 - Objective Tumour Response to M6620 (Berzosertib) Plus Chemotherapy, as Evaluated by CT Scan and Quantified by RECIST 1.1. Missing Data	4 Participants	0 Participants	6 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: 24 weeks

Population: Due to lack of funding, Stage B was not completed.

Any toxicity grade ≥3 graded according to CTCAE v4.03 and length of time for toxicity to resolve.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: Due to lack of funding, Stage B was not completed.

Treatment tolerance and deliverability measured by proportion of patients completing at least 80% of the planned chemotherapy dose and at least 20 fractions of RT.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: Due to lack of funding, Stage B was not completed.

To measure objective tumour response as evaluated by CT scan and quantified by RECIST 1.1 and endoscopic biopsy findings & PFS and OS from D1

Outcome measures

Outcome data not reported

Adverse Events

A1 - Dose Level 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

A1 - Dose Level 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

A1 - Dose Level 3

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

A1 - Dose Level 4

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

A1 - Dose Level 5

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

A1 - Dose Level 6

Serious events: 2 serious events

Other events: 9 other events

Deaths: 5 deaths

A2 - Dose Level 1

Serious events: 0 serious events

Other events: 4 other events

Deaths: 3 deaths

A2 - Dose Level 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

A2 - Dose Level 3

Serious events: 3 serious events

Other events: 9 other events

Deaths: 5 deaths

A2 - Dose Level 4

Serious events: 0 serious events

Other events: 4 other events

Deaths: 2 deaths

Serious adverse events

Measure	A1 - Dose Level 1 n=3 participants at risk Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 9, 16.	A1 - Dose Level 2 n=1 participants at risk Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 3 n=1 participants at risk Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16, 19.	A1 - Dose Level 4 n=1 participants at risk Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 9, 16.	A1 - Dose Level 5 n=1 participants at risk Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 6 n=9 participants at risk Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16, 19.	A2 - Dose Level 1 n=5 participants at risk Cisplatin/capecitabine + M6620 (Berzosertib) administered at 90 mg/m2 once a week for 18 weeks.	A2 - Dose Level 2 n=1 participants at risk Cisplatin/capecitabine + M6620 (Berzosertib) administered at 90 mg/m2 twice a week for 18 weeks.	A2 - Dose Level 3 n=9 participants at risk Cisplatin/capecitabine + M6620 (Berzosertib) administered at 140 mg/m2 once a week for 18 weeks.	A2 - Dose Level 4 n=5 participants at risk Cisplatin/capecitabine + M6620 (Berzosertib) administered at 140 mg/m2 twice a week for 18 weeks.
Injury, poisoning and procedural complications Gastrostomy tube site complication	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	11.1% 1/9 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
General disorders Pyrexia	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	11.1% 1/9 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
General disorders Chest pain	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	11.1% 1/9 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	11.1% 1/9 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Gastrointestinal disorders Constipation	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	11.1% 1/9 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Gastrointestinal disorders Vomiting	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	11.1% 1/9 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	11.1% 1/9 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Infections and infestations Sepsis	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	11.1% 1/9 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).

Other adverse events

Measure	A1 - Dose Level 1 n=3 participants at risk Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 9, 16.	A1 - Dose Level 2 n=1 participants at risk Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 3 n=1 participants at risk Radiotherapy + M6620 (Berzosertib) administered at 140 mg/m2 on days 2, 5, 9, 12, 16, 19.	A1 - Dose Level 4 n=1 participants at risk Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 9, 16.	A1 - Dose Level 5 n=1 participants at risk Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16.	A1 - Dose Level 6 n=9 participants at risk Radiotherapy + M6620 (Berzosertib) administered at 240 mg/m2 on days 2, 5, 9, 12, 16, 19.	A2 - Dose Level 1 n=5 participants at risk Cisplatin/capecitabine + M6620 (Berzosertib) administered at 90 mg/m2 once a week for 18 weeks.	A2 - Dose Level 2 n=1 participants at risk Cisplatin/capecitabine + M6620 (Berzosertib) administered at 90 mg/m2 twice a week for 18 weeks.	A2 - Dose Level 3 n=9 participants at risk Cisplatin/capecitabine + M6620 (Berzosertib) administered at 140 mg/m2 once a week for 18 weeks.	A2 - Dose Level 4 n=5 participants at risk Cisplatin/capecitabine + M6620 (Berzosertib) administered at 140 mg/m2 twice a week for 18 weeks.
Investigations Investigations	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	44.4% 4/9 • Number of events 7 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	20.0% 1/5 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 2 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	55.6% 5/9 • Number of events 21 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	20.0% 1/5 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	22.2% 2/9 • Number of events 2 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 2 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps)	33.3% 1/3 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Vascular disorders Vascular disorders	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	11.1% 1/9 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	44.4% 4/9 • Number of events 5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
General disorders General disorders and administration site conditions	66.7% 2/3 • Number of events 4 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	44.4% 4/9 • Number of events 5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	60.0% 3/5 • Number of events 6 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	55.6% 5/9 • Number of events 13 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	80.0% 4/5 • Number of events 23 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Reproductive system and breast disorders Reproductive system and breast disorders	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	20.0% 1/5 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	33.3% 1/3 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 2 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 2 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	33.3% 3/9 • Number of events 4 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	40.0% 2/5 • Number of events 5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 2 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	22.2% 2/9 • Number of events 2 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	60.0% 3/5 • Number of events 5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Psychiatric disorders Psychiatric disorders	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	11.1% 1/9 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Nervous system disorders Nervous system disorders	33.3% 1/3 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	33.3% 3/9 • Number of events 5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	20.0% 1/5 • Number of events 2 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	11.1% 1/9 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	60.0% 3/5 • Number of events 3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Blood and lymphatic system disorders Blood and lymphatic system disorders	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	33.3% 3/9 • Number of events 5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	40.0% 2/5 • Number of events 5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 2 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	66.7% 6/9 • Number of events 14 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	60.0% 3/5 • Number of events 17 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Ear and labyrinth disorders Ear and labyrinth disorders	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	11.1% 1/9 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	60.0% 3/5 • Number of events 5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Eye disorders Eye disorders	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	11.1% 1/9 • Number of events 2 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	20.0% 1/5 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Gastrointestinal disorders Gastrointestinal disorders	66.7% 2/3 • Number of events 3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	88.9% 8/9 • Number of events 20 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	40.0% 2/5 • Number of events 4 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	66.7% 6/9 • Number of events 15 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	80.0% 4/5 • Number of events 20 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Hepatobiliary disorders Hepatobiliary disorders	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	20.0% 1/5 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	55.6% 5/9 • Number of events 13 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	11.1% 1/9 • Number of events 8 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	40.0% 2/5 • Number of events 3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Renal and urinary disorders Renal and urinary disorders	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	20.0% 1/5 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/9 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	20.0% 1/5 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 2 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	22.2% 2/9 • Number of events 2 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/5 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	33.3% 3/9 • Number of events 4 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	60.0% 3/5 • Number of events 6 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Infections and infestations Infections and infestations	33.3% 1/3 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	11.1% 1/9 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	60.0% 3/5 • Number of events 7 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 6 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	44.4% 4/9 • Number of events 4 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	40.0% 2/5 • Number of events 3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).
Metabolism and nutrition disorders Metabolism and nutrition disorders	0.00% 0/3 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	0.00% 0/1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	55.6% 5/9 • Number of events 6 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	20.0% 1/5 • Number of events 2 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	100.0% 1/1 • Number of events 1 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	55.6% 5/9 • Number of events 8 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).	60.0% 3/5 • Number of events 4 • Stage A1 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 9 weeks post-end of treatment (12 weeks). Stage A2 - adverse events (including serious) are reported from start of M6620 (Berzosertib) treatment to follow up visit at 8 weeks post-end of treatment (26 weeks). Both Stages - Mortality is reported from start of M6620 (Berzosertib) treatment to patient completion of trial at 12 months after start of treatment (12 months).

Additional Information

Dr Ruth Harman, Trial Manager

OCTO, University of Oxford

Phone: 01865 617018

Email: octo-CHARIOT@oncology.ox.ac.uk

Results disclosure agreements

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