Trial Outcomes & Findings for Testing the Addition of M6620 (VX-970, Berzosertib) to Usual Chemotherapy and Radiation for Head and Neck Cancer (NCT NCT02567422)
NCT ID: NCT02567422
Last Updated: 2025-12-04
Results Overview
According to the Cancer Therapy Evaluation Program National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v. 5). The highest grade experienced by the participant will be reported.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
43 participants
Primary outcome timeframe
Up to 6.5 years
Results posted on
2025-12-04
Participant Flow
Participant milestones
| Measure |
Dose Level 1
Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 2
Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 3
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 3 Expansion
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
6
|
11
|
15
|
|
Overall Study
COMPLETED
|
11
|
6
|
11
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing the Addition of M6620 (VX-970, Berzosertib) to Usual Chemotherapy and Radiation for Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=11 Participants
Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 2
n=6 Participants
Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 3
n=11 Participants
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 3 Expansion
n=15 Participants
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
69 Years
n=3 Participants
|
65.5 Years
n=3 Participants
|
59 Years
n=6 Participants
|
59 Years
n=3 Participants
|
61 Years
n=15 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=3 Participants
|
17 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=3 Participants
|
4 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
10 Participants
n=3 Participants
|
26 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=3 Participants
|
6 Participants
n=3 Participants
|
10 Participants
n=6 Participants
|
14 Participants
n=3 Participants
|
41 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=3 Participants
|
6 Participants
n=3 Participants
|
10 Participants
n=6 Participants
|
11 Participants
n=3 Participants
|
35 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=15 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=3 Participants
|
6 participants
n=3 Participants
|
11 participants
n=6 Participants
|
15 participants
n=3 Participants
|
43 participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Up to 6.5 yearsAccording to the Cancer Therapy Evaluation Program National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v. 5). The highest grade experienced by the participant will be reported.
Outcome measures
| Measure |
Dose Level 3
n=11 Participants
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 3 Expansion
n=15 Participants
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 1
n=11 Participants
Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 2
n=6 Participants
Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Grade 3, 4, and 5 Adverse Events
Grade 5
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Grade 3, 4, and 5 Adverse Events
Grade 4
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants Experiencing Grade 3, 4, and 5 Adverse Events
Grade 3
|
5 Participants
|
11 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants Experiencing Grade 3, 4, and 5 Adverse Events
Grades 1-2
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 3 weeks after completion of radiation therapyPopulation: Dose limiting toxicities (DLTs) are only evaluated in participants during dose escalation (i.e. Dose Levels 1, 2, and 3). Participants not completing the treatment for reasons other than an adverse event (i.e. withdrawal or non-compliance with treatment) are excluded from the analysis. DLTs were not evaluated for participants enrolled in Dose Expansion.
Dose limiting toxicities are protocol-specific adverse events considered at least possibly related to the study intervention. Graded according to NCI CTCAE v5.
Outcome measures
| Measure |
Dose Level 3
n=9 Participants
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 3 Expansion
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 1
n=9 Participants
Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 2
n=6 Participants
Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
|---|---|---|---|---|
|
Number of Participants Experiencing a Dose Limiting Toxicities
Experiencing a DLT
|
2 Participants
|
—
|
2 Participants
|
1 Participants
|
|
Number of Participants Experiencing a Dose Limiting Toxicities
Did not experience a DLT
|
7 Participants
|
—
|
7 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to 7 weeksDefined as the highest doses of cisplatin and berzosertib safely combined with radiation.
Outcome measures
| Measure |
Dose Level 3
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 3 Expansion
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 1
n=28 Participants
Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 2
Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
|---|---|---|---|---|
|
Establish the Recommended Phase 2 Dose (RP2D)
|
—
|
—
|
200 mg/m^2
|
—
|
SECONDARY outcome
Timeframe: Up to Day 5Population: Based on samples collected. PK was only collected in the dose escalation phase. PK was not collected for participants in the dose expansion arm.
The maximum concentration ratio between Day -7 collections to Day 2 collections. Collection time points are baseline, 30 and 55 minutes after the start of M6620 infusion, 5, 15, 30 minutes, 1, 2, 4, 23 (Day 3), 48 (Day 4), and 72 hours (Day 5) after the end of M6620 infusion given on Day 2.
Outcome measures
| Measure |
Dose Level 3
n=5 Participants
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 3 Expansion
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 1
n=5 Participants
Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 2
Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
|---|---|---|---|---|
|
Pharmacokinetic Characteristics of Berzosertib
|
1.02 ratio
Standard Deviation 1.5
|
—
|
0.75 ratio
Standard Deviation 1.7
|
—
|
SECONDARY outcome
Timeframe: Up to Day 5Population: Based on samples collected. PK was only collected in the dose escalation phase. PK was not collected for participants in the dose expansion arm.
The maximum concentration of M6620 in the blood when aprepitant is also given.
Outcome measures
| Measure |
Dose Level 3
n=5 Participants
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 3 Expansion
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 1
n=5 Participants
Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 2
Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
|---|---|---|---|---|
|
Potential Drug-drug Interaction
|
1149 ug/L
Standard Deviation 1.9
|
—
|
732 ug/L
Standard Deviation 2.5
|
—
|
SECONDARY outcome
Timeframe: Up to 6.5 yearsEvaluated by Response Evaluation Criteria in Solid Tumors 1.1. Response is defined as complete response (disappearance of all target and non-target lesions) or partial response (at least a 30% decrease in the sum of diameters of target lesions from baseline).
Outcome measures
| Measure |
Dose Level 3
n=11 Participants
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 3 Expansion
n=15 Participants
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 1
n=11 Participants
Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 2
n=6 Participants
Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
|---|---|---|---|---|
|
Number of Participants Experiencing a Response
Response
|
7 Participants
|
7 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants Experiencing a Response
No Response
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing a Response
Not Performed
|
3 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: At week 12 after completing interventionPopulation: Due to funding issues, response was solely assessed by CT scans instead of FDG PET. Metabolic data was therefore not collected.
Assessed by fluorodeoxyglucose-positron emission tomography (FDG PET) and measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Metabolic response are participants demonstrating a complete response (disappearance of all target and non-target lesions) or a partial response (at least a 30% decrease in the sum of diameters of target lesions from baseline).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6.5 yearsKaplan-Meier curves for Progression Free Survival (PFS), defined as time to disease progression, and Overall Survival (OS), defined as time until death or off study, were used to evaluate if the gene expression profiles of ERCC1 and XRCC1, and TP53 correlated to these outcomes.
Outcome measures
| Measure |
Dose Level 3
n=9 Participants
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 3 Expansion
n=9 Participants
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 1
n=8 Participants
Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 2
n=5 Participants
Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
|---|---|---|---|---|
|
Expression of Tissue-based Biomarkers as Markers of Deoxyribonucleic Acid Damage and Predictors of Clinical Outcome
Selected Biomarkers correlated to Outcome
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Expression of Tissue-based Biomarkers as Markers of Deoxyribonucleic Acid Damage and Predictors of Clinical Outcome
Selected Biomarkers did not correlate to Outcome
|
9 Participants
|
9 Participants
|
8 Participants
|
5 Participants
|
Adverse Events
Dose Level 1
Serious events: 5 serious events
Other events: 11 other events
Deaths: 2 deaths
Dose Level 2
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
Dose Level 3
Serious events: 7 serious events
Other events: 11 other events
Deaths: 2 deaths
Dose Level 3 Expansion
Serious events: 5 serious events
Other events: 15 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Dose Level 1
n=11 participants at risk
Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 2
n=6 participants at risk
Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 3
n=11 participants at risk
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 3 Expansion
n=15 participants at risk
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Cardiac disorders
Sinus tachycardia
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Dysphagia
|
18.2%
2/11 • Up to 6.5 years
|
33.3%
2/6 • Up to 6.5 years
|
18.2%
2/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
18.2%
2/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
General disorders
Fatigue
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
18.2%
2/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
General disorders
Fever
|
9.1%
1/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
18.2%
2/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
General disorders
Malaise
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Infections and infestations
infections and infestations: positive blood culture
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
18.2%
2/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Infections and infestations
Tracheitis
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Investigations
Platelet count decreased
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Musculoskeletal and connective tissue disorders
Pseudogout
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
18.2%
2/11 • Up to 6.5 years
|
13.3%
2/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
13.3%
2/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
Other adverse events
| Measure |
Dose Level 1
n=11 participants at risk
Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 2
n=6 participants at risk
Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 3
n=11 participants at risk
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
Dose Level 3 Expansion
n=15 participants at risk
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
81.8%
9/11 • Up to 6.5 years
|
100.0%
6/6 • Up to 6.5 years
|
63.6%
7/11 • Up to 6.5 years
|
73.3%
11/15 • Up to 6.5 years
|
|
Blood and lymphatic system disorders
DVT
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Cardiac disorders
Heart failure
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Cardiac disorders
Heart racing
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Cardiac disorders
Palpitations
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Cardiac disorders
Sinus tachycardia
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
33.3%
5/15 • Up to 6.5 years
|
|
Ear and labyrinth disorders
Ear fullness
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
18.2%
2/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
9.1%
1/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Ear and labyrinth disorders
Heightened sense of hearing
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
9.1%
1/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
36.4%
4/11 • Up to 6.5 years
|
20.0%
3/15 • Up to 6.5 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Endocrine disorders
Hyperthyroidism
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Eye disorders
Dry eye
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Eye disorders
Vision changes'
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Eye disorders
Visual disturbance
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
18.2%
2/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Constipation
|
63.6%
7/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
63.6%
7/11 • Up to 6.5 years
|
46.7%
7/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Diarrhea
|
36.4%
4/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
36.4%
4/11 • Up to 6.5 years
|
20.0%
3/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Dry mouth
|
27.3%
3/11 • Up to 6.5 years
|
33.3%
2/6 • Up to 6.5 years
|
54.5%
6/11 • Up to 6.5 years
|
60.0%
9/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
18.2%
2/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Dysphagia
|
54.5%
6/11 • Up to 6.5 years
|
50.0%
3/6 • Up to 6.5 years
|
63.6%
7/11 • Up to 6.5 years
|
60.0%
9/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
18.2%
2/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
27.3%
3/11 • Up to 6.5 years
|
13.3%
2/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Gastroparesis
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Mouth cavity erythema
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Mouth sores
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
18.2%
2/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
63.6%
7/11 • Up to 6.5 years
|
80.0%
12/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Nausea
|
63.6%
7/11 • Up to 6.5 years
|
83.3%
5/6 • Up to 6.5 years
|
54.5%
6/11 • Up to 6.5 years
|
73.3%
11/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Oral pain
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
18.2%
2/11 • Up to 6.5 years
|
66.7%
4/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
13.3%
2/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Thickened saliva
|
18.2%
2/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Tongue swelling
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
27.3%
3/11 • Up to 6.5 years
|
33.3%
5/15 • Up to 6.5 years
|
|
General disorders
Chills
|
18.2%
2/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
General disorders
Edema limbs
|
18.2%
2/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
36.4%
4/11 • Up to 6.5 years
|
20.0%
3/15 • Up to 6.5 years
|
|
General disorders
Fatigue
|
63.6%
7/11 • Up to 6.5 years
|
66.7%
4/6 • Up to 6.5 years
|
54.5%
6/11 • Up to 6.5 years
|
73.3%
11/15 • Up to 6.5 years
|
|
General disorders
Fever
|
9.1%
1/11 • Up to 6.5 years
|
33.3%
2/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
General disorders
Hemoptysis
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
General disorders
Infusion related reaction
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
General disorders
Infusion site extravasation
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
General disorders
Leg cramp
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
General disorders
Localized edema
|
9.1%
1/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
General disorders
Malaise
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
General disorders
Neck edema
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
General disorders
Pain
|
27.3%
3/11 • Up to 6.5 years
|
33.3%
2/6 • Up to 6.5 years
|
18.2%
2/11 • Up to 6.5 years
|
33.3%
5/15 • Up to 6.5 years
|
|
General disorders
Post-op Delerium
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
General disorders
Soreness gum
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
General disorders
Soreness left side
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Immune system disorders
Allergic reaction
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Infections and infestations
Aspiration pneumonia
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Infections and infestations
Candida Albicans
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Infections and infestations
Thrush
|
9.1%
1/11 • Up to 6.5 years
|
33.3%
2/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
26.7%
4/15 • Up to 6.5 years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Infections and infestations
Tracheitis
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
13.3%
2/15 • Up to 6.5 years
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
13.3%
2/15 • Up to 6.5 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
63.6%
7/11 • Up to 6.5 years
|
100.0%
6/6 • Up to 6.5 years
|
45.5%
5/11 • Up to 6.5 years
|
73.3%
11/15 • Up to 6.5 years
|
|
Injury, poisoning and procedural complications
Fall
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
18.2%
2/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Injury, poisoning and procedural complications
Secretion from trach site
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
9.1%
1/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Investigations
Acute transminitis
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
27.3%
3/11 • Up to 6.5 years
|
13.3%
2/15 • Up to 6.5 years
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Investigations
Aspartate aminotransferase increased
|
18.2%
2/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
26.7%
4/15 • Up to 6.5 years
|
|
Investigations
Blood bilirubin increased
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Investigations
Blood lactate dehydrogenase increase
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
40.0%
6/15 • Up to 6.5 years
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Investigations
Creatinine decreased
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Investigations
Creatinine increased
|
36.4%
4/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
18.2%
2/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Investigations
GGT increased
|
9.1%
1/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
13.3%
2/15 • Up to 6.5 years
|
|
Investigations
Lymphocyte count decreased
|
63.6%
7/11 • Up to 6.5 years
|
66.7%
4/6 • Up to 6.5 years
|
63.6%
7/11 • Up to 6.5 years
|
73.3%
11/15 • Up to 6.5 years
|
|
Investigations
Neutrophil count decreased
|
45.5%
5/11 • Up to 6.5 years
|
50.0%
3/6 • Up to 6.5 years
|
45.5%
5/11 • Up to 6.5 years
|
46.7%
7/15 • Up to 6.5 years
|
|
Investigations
Platelet count decreased
|
63.6%
7/11 • Up to 6.5 years
|
66.7%
4/6 • Up to 6.5 years
|
63.6%
7/11 • Up to 6.5 years
|
66.7%
10/15 • Up to 6.5 years
|
|
Investigations
Weight loss
|
63.6%
7/11 • Up to 6.5 years
|
50.0%
3/6 • Up to 6.5 years
|
81.8%
9/11 • Up to 6.5 years
|
60.0%
9/15 • Up to 6.5 years
|
|
Investigations
White blood cell decreased
|
63.6%
7/11 • Up to 6.5 years
|
66.7%
4/6 • Up to 6.5 years
|
45.5%
5/11 • Up to 6.5 years
|
80.0%
12/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
45.5%
5/11 • Up to 6.5 years
|
33.3%
2/6 • Up to 6.5 years
|
27.3%
3/11 • Up to 6.5 years
|
40.0%
6/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
27.3%
3/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
20.0%
3/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
36.4%
4/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
45.5%
5/11 • Up to 6.5 years
|
26.7%
4/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.1%
1/11 • Up to 6.5 years
|
33.3%
2/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
hyperphosphatemia
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
54.5%
6/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
27.3%
3/11 • Up to 6.5 years
|
20.0%
3/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
36.4%
4/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
27.3%
3/11 • Up to 6.5 years
|
26.7%
4/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
45.5%
5/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
27.3%
3/11 • Up to 6.5 years
|
26.7%
4/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
45.5%
5/11 • Up to 6.5 years
|
83.3%
5/6 • Up to 6.5 years
|
36.4%
4/11 • Up to 6.5 years
|
60.0%
9/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
36.4%
4/11 • Up to 6.5 years
|
50.0%
3/6 • Up to 6.5 years
|
36.4%
4/11 • Up to 6.5 years
|
46.7%
7/15 • Up to 6.5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
27.3%
3/11 • Up to 6.5 years
|
33.3%
2/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Musculoskeletal and connective tissue disorders
Cramping in R foot/ankle
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
18.2%
2/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.2%
2/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
13.3%
2/15 • Up to 6.5 years
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Nervous system disorders
Ageusia
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Nervous system disorders
Dizziness
|
36.4%
4/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
18.2%
2/11 • Up to 6.5 years
|
33.3%
5/15 • Up to 6.5 years
|
|
Nervous system disorders
Dysgeusia
|
54.5%
6/11 • Up to 6.5 years
|
66.7%
4/6 • Up to 6.5 years
|
54.5%
6/11 • Up to 6.5 years
|
53.3%
8/15 • Up to 6.5 years
|
|
Nervous system disorders
Headache
|
27.3%
3/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
27.3%
3/11 • Up to 6.5 years
|
13.3%
2/15 • Up to 6.5 years
|
|
Nervous system disorders
Hyperosmia
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Nervous system disorders
Memory impairment
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.1%
1/11 • Up to 6.5 years
|
33.3%
2/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Nervous system disorders
Subjective diminished fine motor control
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Nervous system disorders
Tremor
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Nervous system disorders
Xtrapyramidal disorder: restless legs
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Psychiatric disorders
Agitation
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
27.3%
3/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Psychiatric disorders
Anxiety
|
18.2%
2/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
13.3%
2/15 • Up to 6.5 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
13.3%
2/15 • Up to 6.5 years
|
|
Psychiatric disorders
Hallucinations
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Psychiatric disorders
Insomnia
|
18.2%
2/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
18.2%
2/11 • Up to 6.5 years
|
20.0%
3/15 • Up to 6.5 years
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Renal and urinary disorders
Urinary retention
|
18.2%
2/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
13.3%
2/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial stricture
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
2/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
18.2%
2/11 • Up to 6.5 years
|
13.3%
2/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.2%
2/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
27.3%
3/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
9.1%
1/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
27.3%
3/11 • Up to 6.5 years
|
33.3%
5/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Odynophagia
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
18.2%
2/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
13.3%
2/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
27.3%
3/11 • Up to 6.5 years
|
50.0%
3/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
20.0%
3/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
27.3%
3/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
27.3%
3/11 • Up to 6.5 years
|
33.3%
5/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sputum
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Throat congestion
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Skin and subcutaneous tissue disorders
Allodynia
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
18.2%
2/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Skin and subcutaneous tissue disorders
Erythema of buccal mucosa
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Skin and subcutaneous tissue disorders
Excoriations around PEG tube insertion site
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Skin and subcutaneous tissue disorders
Radiation mucositis
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
27.3%
3/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Skin and subcutaneous tissue disorders
Redness and local irritation at G tube site
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
13.3%
2/15 • Up to 6.5 years
|
|
Skin and subcutaneous tissue disorders
Skin manifestations
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Skin and subcutaneous tissue disorders
Sores on chin
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Surgical and medical procedures
PEG tube placement
|
18.2%
2/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Surgical and medical procedures
Tracheostomy
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/11 • Up to 6.5 years
|
33.3%
2/6 • Up to 6.5 years
|
27.3%
3/11 • Up to 6.5 years
|
20.0%
3/15 • Up to 6.5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
6.7%
1/15 • Up to 6.5 years
|
|
Vascular disorders
Lymphedema
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
13.3%
2/15 • Up to 6.5 years
|
|
Vascular disorders
Phlebitis
|
0.00%
0/11 • Up to 6.5 years
|
16.7%
1/6 • Up to 6.5 years
|
0.00%
0/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
|
Vascular disorders
Thromboembolic event
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/6 • Up to 6.5 years
|
9.1%
1/11 • Up to 6.5 years
|
0.00%
0/15 • Up to 6.5 years
|
Additional Information
Grants Administrative Manager
Johns Hopkins University/SKCCC
Phone: 4439273568
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60