Trial Outcomes & Findings for Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity (NCT NCT01265849)
NCT ID: NCT01265849
Last Updated: 2022-08-19
Results Overview
OS was assessed using Kaplan-Meier life-table using a log rank test and confirmed further with tumor stage, tumor location, and geographic stratified log rank test. Both Stratified and unstratified log rank test are presented with the unstratified log rank test constituting the primary analysis. A two-sided p-value of 0.05 or less was considered statistically significant for comparing the two groups (i.e., Study comparator arms: LI+CIZ+SOC vs. SOC alone). Interim analyses were performed (by the iDMC) periodically throughout the study to assess safety, sample size and futility.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
928 participants
Primary outcome timeframe
From the date of treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.
Results posted on
2022-08-19
Participant Flow
Participant milestones
| Measure |
LI + CIZ + SOC
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as adjuvant therapy prior to standard of care (SOC).
|
Standard of Care (SOC)
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for recurrence determined at surgery.
|
LI + SOC
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
|---|---|---|---|
|
Overall Study
STARTED
|
396
|
398
|
134
|
|
Overall Study
COMPLETED
|
350
|
337
|
115
|
|
Overall Study
NOT COMPLETED
|
46
|
61
|
19
|
Reasons for withdrawal
| Measure |
LI + CIZ + SOC
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as adjuvant therapy prior to standard of care (SOC).
|
Standard of Care (SOC)
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for recurrence determined at surgery.
|
LI + SOC
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
|---|---|---|---|
|
Overall Study
Randomized//Treatment not initiated
|
1
|
4
|
0
|
|
Overall Study
Physician Decision
|
1
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
18
|
15
|
5
|
|
Overall Study
Not otherwise specified
|
1
|
6
|
1
|
|
Overall Study
Withdrawal by Subject
|
25
|
34
|
13
|
Baseline Characteristics
Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity
Baseline characteristics by cohort
| Measure |
LI + CIZ + SOC
n=395 Participants
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as neoadjuvant therapy prior to standard of care (SOC).
|
Standard of Care (SOC)
n=394 Participants
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
LI + SOC
n=134 Participants
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Total
n=923 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.5 years
n=5 Participants
|
56.9 years
n=7 Participants
|
55.9 years
n=5 Participants
|
56.6 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
191 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
312 Participants
n=5 Participants
|
315 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
732 Participants
n=4 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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
190 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
433 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
205 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
490 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
79 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
311 Participants
n=5 Participants
|
317 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
736 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
Malaysia
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Region of Enrollment
Philippines
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
7 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Region of Enrollment
Thailand
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
India
|
37 participants
n=5 Participants
|
38 participants
n=7 Participants
|
11 participants
n=5 Participants
|
86 participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
Sri Lanka
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
7 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
Region of Enrollment
Bosnia and Herzegovina
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
6 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Region of Enrollment
Serbia
|
78 participants
n=5 Participants
|
79 participants
n=7 Participants
|
26 participants
n=5 Participants
|
183 participants
n=4 Participants
|
|
Region of Enrollment
Turkey
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
Belarus
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
7 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
Region of Enrollment
Russia
|
76 participants
n=5 Participants
|
76 participants
n=7 Participants
|
26 participants
n=5 Participants
|
178 participants
n=4 Participants
|
|
Region of Enrollment
Ukraine
|
68 participants
n=5 Participants
|
67 participants
n=7 Participants
|
23 participants
n=5 Participants
|
158 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Croatia
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
8 participants
n=5 Participants
|
55 participants
n=4 Participants
|
|
Region of Enrollment
France
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
3 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
6 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Primary Tumor Location
Cheek (Buccal Mucosa)
|
53 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Primary Tumor Location
Floor of Mouth
|
111 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
264 Participants
n=4 Participants
|
|
Primary Tumor Location
Oral Tongue
|
182 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
423 Participants
n=4 Participants
|
|
Primary Tumor Location
Soft Palate
|
49 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
|
Tumor Code
T1: Tumor < 2 cm in greatest dimension
|
21 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Tumor Code
T2: Tumor > 2 and < 4 cm in greatest dimension or extension to lingual surface of epiglottis
|
94 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
217 Participants
n=4 Participants
|
|
Tumor Code
T3: Tumor more than 4 cm in greatest dimension
|
163 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
422 Participants
n=4 Participants
|
|
Tumor Code
T4a: Moderately advanced local disease
|
117 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
247 Participants
n=4 Participants
|
|
Number of Nodes Involved
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Number of Nodes Involved
N0
|
190 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
432 Participants
n=4 Participants
|
|
Number of Nodes Involved
N1
|
108 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
263 Participants
n=4 Participants
|
|
Number of Nodes Involved
N2
|
96 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
227 Participants
n=4 Participants
|
|
TNM Stage
TNM Stage III
|
218 Participants
n=5 Participants
|
228 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
521 Participants
n=4 Participants
|
|
TNM Stage
TNM Stage IV
|
177 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
402 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From the date of treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.Population: Intent to Treat Population
OS was assessed using Kaplan-Meier life-table using a log rank test and confirmed further with tumor stage, tumor location, and geographic stratified log rank test. Both Stratified and unstratified log rank test are presented with the unstratified log rank test constituting the primary analysis. A two-sided p-value of 0.05 or less was considered statistically significant for comparing the two groups (i.e., Study comparator arms: LI+CIZ+SOC vs. SOC alone). Interim analyses were performed (by the iDMC) periodically throughout the study to assess safety, sample size and futility.
Outcome measures
| Measure |
LI + CIZ + SOC
n=395 Participants
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as neoadjuvant therapy prior to standard of care (SOC).
|
LI + SOC
n=134 Participants
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Standard of Care (SOC)
n=394 Participants
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
|---|---|---|---|
|
Overall Survival (OS)
|
46.3 months
Interval 39.3 to 55.0
|
58.1 months
Interval 41.4 to 68.2
|
52.9 months
Interval 46.5 to 66.6
|
PRIMARY outcome
Timeframe: From the date of treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.Population: Low Risk Intent to Treat Population
OS was assessed using Kaplan-Meier life-table using a log rank test and confirmed further with tumor stage, tumor location, and geographic stratified log rank test. Both Stratified and unstratified log rank test are presented with the unstratified log rank test constituting the primary analysis. A two-sided p-value of 0.05 or less was considered statistically significant for comparing the two groups (i.e., Study comparator arms: LI+CIZ+SOC vs. SOC alone). Low-risk assessment and data analysis was never performed during the study and was done only after database lock.
Outcome measures
| Measure |
LI + CIZ + SOC
n=158 Participants
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as neoadjuvant therapy prior to standard of care (SOC).
|
LI + SOC
n=54 Participants
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Standard of Care (SOC)
n=168 Participants
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
|---|---|---|---|
|
OS in Low Risk Subjects
|
101.7 months
Interval 64.1 to 101.7
|
68.2 months
Interval 44.7 to
The upper limit for the 95% Confidence Interval cannot be estimated, "Too few events ".
|
55.2 months
Interval 48.0 to
The upper limit for the 95% Confidence Interval cannot be estimated, "Too few events".
|
SECONDARY outcome
Timeframe: From the date of treatment assignment to LRC or the last follow-up date. Maximum follow-up was approximately 113 months.Population: Intent to treat population
LRC is defined as the number of months from randomization to the date of documented local or regional failure (recurrence or progression) or date of last follow-up or death. LRC failure includes the reappearance (recurrence) of disease (at the original tumor sites), progressive disease (but not distant metastases), or any new disease (including new disease in lymph nodes), above the clavicle, not present at baseline. This is the traditional RTOG measure of local-regional control, also referred to as Freedom from Local Progression.
Outcome measures
| Measure |
LI + CIZ + SOC
n=395 Participants
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as neoadjuvant therapy prior to standard of care (SOC).
|
LI + SOC
n=134 Participants
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Standard of Care (SOC)
n=394 Participants
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
|---|---|---|---|
|
Local Regional Control (LRC)
|
NA months
Too few events occurred to estimate the median (95% CI) time-to-event.
|
NA months
Too few events occurred to estimate the median (95% CI) time-to-event.
|
NA months
Too few events occurred to estimate the median (95% CI) time-to-event.
|
SECONDARY outcome
Timeframe: From the date of treatment assignment to LRC or the last follow-up date. Maximum follow-up was approximately 113 months.Population: Low Risk Intent to Treat Population
LRC is defined as the number of months from randomization to the date of documented local or regional failure (recurrence or progression) or date of last follow-up or death. LRC failure includes the reappearance (recurrence) of disease (at the original tumor sites), progressive disease (but not distant metastases), or any new disease (including new disease in lymph nodes), above the clavicle, not present at baseline. This is the traditional RTOG measure of local-regional control, also referred to as Freedom from Local Progression. Low risk assessment and data analysis was never performed during the study and was done only after database lock.
Outcome measures
| Measure |
LI + CIZ + SOC
n=158 Participants
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as neoadjuvant therapy prior to standard of care (SOC).
|
LI + SOC
n=54 Participants
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Standard of Care (SOC)
n=168 Participants
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
|---|---|---|---|
|
LRC in Low Risk Subjects
|
NA months
Too few events occurred to estimate the median (95% CI) time-to-event.
|
NA months
Too few events occurred to estimate the median (95% CI) time-to-event.
|
NA months
Too few events occurred to estimate the median (95% CI) time-to-event.
|
SECONDARY outcome
Timeframe: From the date of treatment assignment to PFS or the last follow-up date. Maximum follow-up was approximately 113 months.Population: Intent to Treat Population
PFS is defined as the number of months from randomization to the date of first documented, progressive disease (any tumor recurrence, any new disease above clavicle or distant metastases) or the date of last follow-up or death. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest dimension (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
LI + CIZ + SOC
n=395 Participants
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as neoadjuvant therapy prior to standard of care (SOC).
|
LI + SOC
n=134 Participants
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Standard of Care (SOC)
n=394 Participants
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
32.4 months
Interval 25.5 to 43.4
|
37.0 months
Interval 19.4 to 57.4
|
45.5 months
Interval 23.5 to 51.2
|
SECONDARY outcome
Timeframe: From the date of treatment assignment to PFS or the last follow-up date. Maximum follow-up was approximately 113 months.Population: Low Risk Intent to treat population
PFS is defined as the number of months from randomization to the date of first documented, progressive disease (any tumor recurrence, any new disease above clavicle or distant metastases) or the date of last follow-up or death. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest dimension (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions. Low risk assessment and data analysis was not performed during the study and was performed only after database lock.
Outcome measures
| Measure |
LI + CIZ + SOC
n=158 Participants
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as neoadjuvant therapy prior to standard of care (SOC).
|
LI + SOC
n=54 Participants
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Standard of Care (SOC)
n=168 Participants
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
|---|---|---|---|
|
PFS in Low Risk Subjects
|
66.4 months
Interval 47.5 to 101.7
|
68.2 months
Interval 37.0 to 112.4
|
51.5 months
Interval 42.5 to 72.2
|
SECONDARY outcome
Timeframe: Global Health Status (GHS) at Baseline [pre-randomization], Long Term Follow-up Month 2Population: Overall number of participants analyzed is the total number of subjects in the longitudinal model. The number of participants analyzed is the number of subjects assessed at each visit. This study is not powered for quality of life comparisons.
The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 (EORTC QLQ-C30) V3.0 is composed of both multi-item scales and single-item measures. The Global Health Scale/QoL multi-item scale \[GHS\] is a comprised of two Items: Item 29 "How would you rate your overall health during the past week?", and item 30: "How would you rate your overall quality of life during the past week?". Both items are 7 point scales ranging from a score of 1 (very poor) to 7 (Excellent). The GHS is constructed by averaging Items 29 and 30 to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation GHS=100\*\[(RS-1)/6\]. A higher score represents a higher ("better") QoL. Change in GHS is calculated as Observed - Baseline, so a positive change in GHS is improved QoL. Treatment comparisons are active treatment arms minus SOC, so a positive difference favors active treatment.
Outcome measures
| Measure |
LI + CIZ + SOC
n=117 Participants
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as neoadjuvant therapy prior to standard of care (SOC).
|
LI + SOC
n=37 Participants
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Standard of Care (SOC)
n=119 Participants
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
|---|---|---|---|
|
Quality of Life by EORTC QLQ-C30 Global Health Status [GHS] at Month 2
|
0.28 units on a scale (0-100)
Standard Error 1.82
|
7.95 units on a scale (0-100)
Standard Error 3.03
|
3.29 units on a scale (0-100)
Standard Error 1.83
|
SECONDARY outcome
Timeframe: Global Health Status (GHS) at Baseline [pre-randomization], Long Term Follow-up Month 36Population: Overall number of participants analyzed is the total number of subjects with data at this visit. The number of participants analyzed is the number of subjects assessed at each visit. This study is not powered for quality of life comparisons.
The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 (EORTC QLQ-C30) V3.0 is composed of both multi-item scales and single-item measures. The Global Health Scale/QoL multi-item scale \[GHS\] is a comprised of two Items: Item 29 "How would you rate your overall health during the past week?", and item 30: "How would you rate your overall quality of life during the past week?". Both items are 7 point scales ranging from a score of 1 (very poor) to 7 (Excellent). The GHS is constructed by averaging Items 29 and 30 to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation GHS=100\*\[(RS-1)/6\]. A higher score represents a higher ("better") QoL. Change in GHS is calculated as Observed - Baseline, so a positive change in GHS is improved QoL. Treatment comparisons are active treatment arms minus SOC, so a positive difference favors active treatment.
Outcome measures
| Measure |
LI + CIZ + SOC
n=112 Participants
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as neoadjuvant therapy prior to standard of care (SOC).
|
LI + SOC
n=44 Participants
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Standard of Care (SOC)
n=119 Participants
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
|---|---|---|---|
|
Quality of Life by EORTC QLQ-C30 Global Health Status [GHS] at Month 36
|
7.64 units on a scale (0-100)
Standard Error 1.82
|
10.79 units on a scale (0-100)
Standard Error 2.85
|
6.33 units on a scale (0-100)
Standard Error 1.80
|
SECONDARY outcome
Timeframe: Baseline [pre-randomization], Long Term Follow-up Month 2Population: Overall number of participants analyzed is the total number of subjects in data at that visit. The number of participants analyzed is the number of subjects assessed at each visit. This study is not powered for quality of life comparisons.
The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 supplementary Head \& neck cancer module (EORTC QLQ-C30 - QLQ H\&N35) items 1-4 make up the symptom score for pain, items 5-8 for swallowing. The 4 pain questions score: "pain in your mouth, pain in your jaw, soreness in your mouth, a painful throat?" The 4 swallowing questions score "problems swallowing: liquids, pureed food, solid food, choking? Item are scored as 1 (Not at all) to 4 (Very much). Each symptom scale is constructed by averaging the 4 items to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation symptom score (pain or swallowing)=100\*\[(RS-1)/3\]. A high score for these symptom scales represents a high level of symptoms.Change in symptom is calculated as Observed - Baseline, so a negative change is reduced symptomatology . Treatment comparisons are active treatment arms minus SOC, so a negative difference favors active treatment.
Outcome measures
| Measure |
LI + CIZ + SOC
n=117 Participants
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as neoadjuvant therapy prior to standard of care (SOC).
|
LI + SOC
n=37 Participants
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Standard of Care (SOC)
n=120 Participants
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
|---|---|---|---|
|
EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 2
Change from Baseline in Head & Neck PAIN at Long Term Follow-up Month 2
|
-2.75 units on a scale (0-100)
Standard Error 1.66
|
-2.80 units on a scale (0-100)
Standard Error 2.77
|
-3.81 units on a scale (0-100)
Standard Error 1.67
|
|
EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 2
Change from Baseline in Head & Neck SWALLOWING at Long Term Follow-up Month 2
|
8.11 units on a scale (0-100)
Standard Error 1.88
|
6.29 units on a scale (0-100)
Standard Error 3.13
|
7.31 units on a scale (0-100)
Standard Error 1.89
|
SECONDARY outcome
Timeframe: Baseline [pre-randomization], Long Term Follow-up Month 36Population: Overall number of participants analyzed is the total number of subjects with data at this visit. The number of participants analyzed is the number of subjects assessed at each visit. This study is not powered for quality of life comparisons.
The European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30 Version 3.0 supplementary Head \& neck cancer module (EORTC QLQ-C30 - QLQ H\&N35) items 1-4 make up the symptom score for pain, items 5-8 for swallowing. The 4 pain questions score: "pain in your mouth, pain in your jaw, soreness in your mouth, a painful throat?" The 4 swallowing questions score "problems swallowing: liquids, pureed food, solid food, choking? Item are scored as 1 (Not at all) to 4 (Very much). Each symptom scale is constructed by averaging the 4 items to obtain a raw score (RS). The RS is then transformed to a 0-100 scale by the equation symptom score (pain or swallowing)=100\*\[(RS-1)/3\]. A high score for these symptom scales represents a high level of symptoms.Change in symptom is calculated as Observed - Baseline, so a negative change is reduced symptomatology . Treatment comparisons are active treatment arms minus SOC, so a negative difference favors active treatment.
Outcome measures
| Measure |
LI + CIZ + SOC
n=112 Participants
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as neoadjuvant therapy prior to standard of care (SOC).
|
LI + SOC
n=44 Participants
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Standard of Care (SOC)
n=120 Participants
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
|---|---|---|---|
|
EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 36
Change from Baseline in Head & Neck PAIN at Long Term Follow-up Month 36
|
-9.47 units on a scale (0-100)
Standard Error 1.66
|
-8.63 units on a scale (0-100)
Standard Error 2.61
|
-8.42 units on a scale (0-100)
Standard Error 1.64
|
|
EORTC Quality of Life Questionnaire (QLQ) - Head & Neck Cancer Module: QLQ-H&N35 at Month 36
Change from Baseline in Head & Neck SWALLOWING at Long Term Follow-up Month 36
|
6.90 units on a scale (0-100)
Standard Error 1.89
|
1.66 units on a scale (0-100)
Standard Error 2.96
|
8.94 units on a scale (0-100)
Standard Error 1.86
|
SECONDARY outcome
Timeframe: From the date of treatment assignment to event (LRC,PFS,OS) or the last follow-up date. Maximum follow-up was approximately 113 months.Population: The analysis population is the Low Risk Intent to treat Population who had HP marker levels assessed and were in either treatment arm LI + CIZ + SOC or SOC. This includes 82 subjects in LI + CIZ + SOC and 95 subjects in standard of care (SOC). No statistical comparisons were made for the 33 Low Risk subjects with HP markers in treatment arm LI + SOC. No data were collected for this Outcome Measure for treatment arm LI + SOC..
HP analysis was performed in a blinded manner by a central pathology laboratory at the end of the study on available samples. To examine potential effects of HP markers on time-to-event efficacy outcomes (OS, LRC, PFS), participants were classified by HP marker levels: 20 HP markers were classified as (low, medium, high), 2 HP ratios as (low, medium, high) and 14 HP combinations as (low, high), resulting in 94 (20\*3+2\*3+2\*14) possible treatment comparisons of LI + CIZ + SOC to SOC. A total of 282 (94 x 3 efficacy outcomes) statistical tests (Cox proportional hazards regressions to test for a significant treatment effect in the model) were made. Significance (two-sided p\<0.05 favoring LI + CIZ + SOC) were reported under LI + CIZ + SOC. Significant test results favoring SOC were reported under SOC. The total number of statistical comparisons between LI + CIZ + SOC and SOC (282) is reported under both arms.
Outcome measures
| Measure |
LI + CIZ + SOC
n=282 Number of statistical tests
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as neoadjuvant therapy prior to standard of care (SOC).
|
LI + SOC
n=282 Number of statistical tests
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Standard of Care (SOC)
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
|---|---|---|---|
|
Statistical Comparisons of Time-to-event Outcomes (OS, LRC, PFS) Were Repeated for Varying Levels of Histopathology (HP) Markers in Low Risk Subjects
|
61 N of Statistically Significant Results
|
0 N of Statistically Significant Results
|
—
|
POST_HOC outcome
Timeframe: From treatment assignment to planned surgery, 29-38 days for LI treated groups and as soon as practicable with within 8 - 38 days for the SOC group (median 33 days).Population: Intent to Treat Population
Tumor response is evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and confirmed by pathology at surgery. For target lesions as assessed by MRI or CT: Complete Response (CR) is disappearance of all target and non-target lesions, no new tumors, and normalization of tumor marker level. Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD) of target lesions taken as a reference the baseline sum of LDs, and no new tumors. Objective response = CR + PR. Response was assessed to LI treatment and compared to controls (SOC) from randomization to surgery in the ITT population for recurrence.
Outcome measures
| Measure |
LI + CIZ + SOC
n=395 Participants
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as neoadjuvant therapy prior to standard of care (SOC).
|
LI + SOC
n=134 Participants
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Standard of Care (SOC)
n=394 Participants
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
|---|---|---|---|
|
Tumor Response by RECIST 1.0
Complete Response (CR)
|
5 participants
|
0 participants
|
0 participants
|
|
Tumor Response by RECIST 1.0
Partial Response (PR)
|
27 participants
|
13 participants
|
0 participants
|
|
Tumor Response by RECIST 1.0
Objective Response (CR+PR)
|
32 participants
|
13 participants
|
0 participants
|
POST_HOC outcome
Timeframe: From treatment assignment to planned surgery, 29-38 days for LI treated groups and as soon as practicable with within 8 - 38 days for the SOC group (median 33 days).Population: Low Risk Intent to Treat Population
Tumor response was evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). For target lesions as assessed by MRI or CT: Complete Response (CR) is disappearance of all target and non-target lesions, no new tumors, and normalization of tumor marker level. Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD) of target lesions taken as a reference the baseline sum of LDs, and no new tumors. Objective response = CR + PR. Response was assessed to LI treatment and compared to controls (SOC) from randomization to surgery in the lower risk ITT population for recurrence.
Outcome measures
| Measure |
LI + CIZ + SOC
n=158 Participants
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as neoadjuvant therapy prior to standard of care (SOC).
|
LI + SOC
n=54 Participants
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Standard of Care (SOC)
n=168 Participants
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
|---|---|---|---|
|
Tumor Response by RECIST 1.0 in Low Risk Subjects
Complete Response (CR)
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Tumor Response by RECIST 1.0 in Low Risk Subjects
Partial Response (PR)
|
19 Participants
|
10 Participants
|
0 Participants
|
|
Tumor Response by RECIST 1.0 in Low Risk Subjects
Objective Response (CR+PR)
|
24 Participants
|
10 Participants
|
0 Participants
|
POST_HOC outcome
Timeframe: Objective Response: from treatment assignment to surgery: 29-38 days for LI-treated & 8-38 days for SOC (median 33 days). Survival from treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.Population: Intent to Treat Population
Survival is assessed as dead or alive at last follow-up. Tumor response is evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). For target lesions as assessed by MRI or CT: Complete Response (CR) is disappearance of all target and non-target lesions, no new tumors, and normalization of tumor marker level. Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD) of target lesions taken as a reference the baseline sum of LDs, and no new tumors. Objective response = CR + PR.
Outcome measures
| Measure |
LI + CIZ + SOC
n=395 Participants
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as neoadjuvant therapy prior to standard of care (SOC).
|
LI + SOC
n=134 Participants
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Standard of Care (SOC)
n=394 Participants
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
|---|---|---|---|
|
Survival by Objective Response (CR+PR)
Non-responder and Alive
|
166 Participants
|
56 Participants
|
204 Participants
|
|
Survival by Objective Response (CR+PR)
Non-responder and Dead
|
197 Participants
|
65 Participants
|
190 Participants
|
|
Survival by Objective Response (CR+PR)
Responder and Alive
|
25 Participants
|
10 Participants
|
0 Participants
|
|
Survival by Objective Response (CR+PR)
Responder and Dead
|
7 Participants
|
3 Participants
|
0 Participants
|
POST_HOC outcome
Timeframe: Objective Response: from treatment assignment to surgery: 29-38 days for LI-treated & 8-38 days for SOC (median 33 days). Survival from treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.Population: Low Risk Intent to Treat Population
OS is assessed as dead or alive at last follow-up. Tumor response is evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). For target lesions as assessed by MRI or CT: Complete Response (CR) is disappearance of all target and non-target lesions, no new tumors, and normalization of tumor marker level. Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD) of target lesions taken as a reference the baseline sum of LDs, and no new tumors. Objective response = CR + PR.
Outcome measures
| Measure |
LI + CIZ + SOC
n=158 Participants
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as neoadjuvant therapy prior to standard of care (SOC).
|
LI + SOC
n=54 Participants
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Standard of Care (SOC)
n=168 Participants
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
|---|---|---|---|
|
Survival by Objective Response (CR+PR) in Low Risk Subjects
Non-responder and Alive
|
79 Participants
|
23 Participants
|
84 Participants
|
|
Survival by Objective Response (CR+PR) in Low Risk Subjects
Non-responder and Dead
|
55 Participants
|
21 Participants
|
84 Participants
|
|
Survival by Objective Response (CR+PR) in Low Risk Subjects
Responder and Alive
|
21 Participants
|
7 Participants
|
0 Participants
|
|
Survival by Objective Response (CR+PR) in Low Risk Subjects
Responder and Dead
|
3 Participants
|
3 Participants
|
0 Participants
|
POST_HOC outcome
Timeframe: Objective Response: from treatment assignment to surgery: 29-38 days for LI-treated & 8-38 days for SOC (median 33 days). Survival from treatment assignment to death or the last follow-up date. Maximum follow-up was approximately 113 months.Population: Low risk Intent to Treat Population
OS is assessed using Kaplan-Meier life-table using an unstratified log rank test and a stratified log rank test, stratified by tumor stage, tumor location, and geographic region. Alive at last follow-up was was censored. Tumor response is evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). For target lesions as assessed by MRI or CT: Complete Response (CR) is disappearance of all target and non-target lesions, no new tumors, and normalization of tumor marker level. Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD) of target lesions taken as a reference the baseline sum of LDs, and no new tumors. Objective response = CR + PR.
Outcome measures
| Measure |
LI + CIZ + SOC
n=158 Participants
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as neoadjuvant therapy prior to standard of care (SOC).
|
LI + SOC
n=54 Participants
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Standard of Care (SOC)
n=168 Participants
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
|---|---|---|---|
|
Overall Survival by Objective Response (CR+PR) in Low Risk Subjects
Non-responder and Alive
|
79 participants
|
23 participants
|
84 participants
|
|
Overall Survival by Objective Response (CR+PR) in Low Risk Subjects
Non-responder and Dead
|
55 participants
|
21 participants
|
84 participants
|
|
Overall Survival by Objective Response (CR+PR) in Low Risk Subjects
Responder and Alive
|
21 participants
|
7 participants
|
0 participants
|
|
Overall Survival by Objective Response (CR+PR) in Low Risk Subjects
Responder and Dead
|
3 participants
|
3 participants
|
0 participants
|
Adverse Events
LI + CIZ + SOC
Serious events: 216 serious events
Other events: 354 other events
Deaths: 204 deaths
LI + SOC
Serious events: 70 serious events
Other events: 124 other events
Deaths: 68 deaths
Standard of Care (SOC)
Serious events: 187 serious events
Other events: 352 other events
Deaths: 190 deaths
Serious adverse events
| Measure |
LI + CIZ + SOC
n=383 participants at risk
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as adjuvant therapy prior to standard of care (SOC).
|
LI + SOC
n=129 participants at risk
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Standard of Care (SOC)
n=367 participants at risk
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
26.1%
100/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
24.8%
32/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
20.2%
74/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer recurrent
|
4.7%
18/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
4.7%
6/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
4.9%
18/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
Death
|
4.7%
18/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
3.1%
4/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
4.6%
17/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Pneumonia
|
2.3%
9/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
1.6%
2/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
3.0%
11/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
1.6%
6/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
2.5%
9/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
2.1%
8/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
1.6%
2/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
1.4%
5/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Oral cavity fistula
|
1.6%
6/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.82%
3/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.0%
4/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
1.6%
2/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
1.1%
4/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Cellulitis
|
1.3%
5/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
1.6%
2/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.54%
2/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.78%
3/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
1.4%
5/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Sepsis
|
1.0%
4/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.82%
3/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Cardiac disorders
Cardiac arrest
|
0.52%
2/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
1.6%
2/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.82%
3/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Postoperative wound infection
|
0.52%
2/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
1.1%
4/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
1.0%
4/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.82%
3/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Stomatitis
|
0.52%
2/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
1.1%
4/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.78%
3/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.54%
2/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral cavity cancer metastatic
|
0.52%
2/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
1.1%
4/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
General physical health deterioration
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
1.4%
5/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Osteoradionecrosis
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
1.6%
2/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.54%
2/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.52%
2/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.54%
2/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.52%
2/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.54%
2/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.52%
2/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.82%
3/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.54%
2/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.78%
3/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
Mucosal inflammation
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.54%
2/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
Sudden death
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.82%
3/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.54%
2/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.78%
3/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue cancer recurrent
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.54%
2/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.78%
3/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.52%
2/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.52%
2/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.54%
2/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Cardiac disorders
Myocardial infarction
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Abscess neck
|
0.52%
2/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Wound infection
|
0.52%
2/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.54%
2/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.54%
2/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.52%
2/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
1.6%
2/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.52%
2/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
1.6%
2/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Psychiatric disorders
Completed suicide
|
0.78%
3/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.52%
2/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.52%
2/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
1.6%
2/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
1.6%
2/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.52%
2/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Tongue movement disturbance
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Tongue necrosis
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Vomiting
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
Complication associated with device
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Osteomyelitis
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Peritonitis
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Septic shock
|
0.52%
2/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Subcutaneous abscess
|
0.52%
2/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Radiation mucositis
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.54%
2/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.54%
2/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Cardiac disorders
Coronary artery disease
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Cardiac disorders
Pericardial effusion
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Eye disorders
Diplopia
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Anal fistula
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Constipation
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Dysphagia
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Enteritis
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Glossitis
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Oesophageal compression
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Oral mucosal hypertrophy
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Oroantral fistula
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Submaxillary gland enlargement
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
Accidental death
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
Asthenia
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
Face oedema
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
Fatigue
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
Impaired healing
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
Implant site ulcer
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
Localised oedema
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
Organ failure
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
Pyrexia
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
Sudden cardiac death
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Abscess
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Cystitis
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Hepatitis B
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Ludwig angina
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Lung abscess
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Oral infection
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Pulmonary mycosis
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Rectal abscess
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Sepsis syndrome
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Sinusitis
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Tooth infection
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Urinary tract infection
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Infections and infestations
Wound abscess
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Flap necrosis
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Postoperative adhesion
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Scar
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Skin flap necrosis
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Skin graft contracture
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Investigations
Oxygen saturation decreased
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Investigations
Weight decreased
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epiglottic cancer
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer stage IV
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to salivary gland
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal cavity cancer
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal sinus cancer
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary malignancy
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the hypopharynx
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue cancer metastatic
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tracheal cancer
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Nervous system disorders
Cranial nerve palsies multiple
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Nervous system disorders
Ischaemic stroke
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Nervous system disorders
Seizure
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Nervous system disorders
Syncope
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal swelling
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Vascular disorders
Deep vein thrombosis
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Vascular disorders
Lymphoedema
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Vascular disorders
Lymphorrhoea
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.78%
1/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.26%
1/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.00%
0/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
0.27%
1/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
Other adverse events
| Measure |
LI + CIZ + SOC
n=383 participants at risk
LI plus CIZ (cyclophosphamide, indomethacin and zinc) is given as adjuvant therapy prior to standard of care (SOC).
|
LI + SOC
n=129 participants at risk
LI is administered without CIZ to determine the contribution of CIZ to the effects of LI.
|
Standard of Care (SOC)
n=367 participants at risk
SOC for previously untreated SCCHN patients is currently surgery followed by either radiotherapy or combined radiochemotherapy depending the patient's risk status for relapse determined at surgery.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
64/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
20.2%
26/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
18.5%
68/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.4%
36/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
9.3%
12/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
8.7%
32/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.6%
33/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
6.2%
8/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
9.8%
36/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Constipation
|
7.6%
29/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
7.0%
9/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
6.0%
22/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Dry mouth
|
10.4%
40/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
8.5%
11/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
13.1%
48/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
48/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
13.2%
17/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
10.9%
40/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Nausea
|
9.9%
38/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
12.4%
16/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
9.3%
34/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Oral pain
|
8.1%
31/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
14.0%
18/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
8.7%
32/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Stomatitis
|
13.1%
50/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
17.1%
22/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
17.2%
63/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Gastrointestinal disorders
Vomiting
|
7.6%
29/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
10.9%
14/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
6.5%
24/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
Asthenia
|
7.6%
29/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
12.4%
16/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
10.6%
39/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
Mucosal inflammation
|
31.6%
121/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
33.3%
43/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
31.9%
117/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
General disorders
Pyrexia
|
11.2%
43/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
12.4%
16/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
9.8%
36/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
8.1%
31/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
10.1%
13/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
10.1%
37/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Radiation injury
|
12.3%
47/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
10.1%
13/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
13.4%
49/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Radiation mucositis
|
7.3%
28/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
11.6%
15/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
8.2%
30/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
18.5%
71/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
24.0%
31/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
21.0%
77/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Investigations
Blood creatinine increased
|
7.0%
27/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
6.2%
8/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
6.8%
25/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Investigations
Lymphocyte count decreased
|
6.0%
23/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
4.7%
6/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
7.1%
26/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Investigations
Weight decreased
|
44.1%
169/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
43.4%
56/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
45.8%
168/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.7%
18/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
5.4%
7/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
5.7%
21/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
12.5%
48/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
10.1%
13/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
3.0%
11/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Psychiatric disorders
Insomnia
|
6.5%
25/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
3.9%
5/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
5.7%
21/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
25/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
3.1%
4/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
4.6%
17/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
12.5%
48/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
9.3%
12/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
11.7%
43/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
7.3%
28/383 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
5.4%
7/129 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
5.4%
20/367 • Adverse events were reported from the signing of informed consent to the end of the study treatment follow-up. Participants were followed through 60 days after the last radio/chemoradiotherapy. Median last day of radiation-only was 122 days (IQR 106, 132 days). Median last day of chemotherapy for participants receiving both radiation and chemotherapy was 112 days (IQR 96, 129 days). Median AE follow-up was approximately six months post radiotherapy/chemoradiotherapy.
All-cause mortality reports 462 deaths in the ITT population (at risk N=923). All-cause mortality includes the 5 deaths for the 44 subjects excluded from the safety population because they were not treated in this study. Adverse events were reported for the safety population (at risk N=879). Five (5) deaths are reported in all-cause mortality that are not reported in the adverse event module.
|
Additional Information
John Cipriano, Senior VP Regulatory Affairs, Eyal Talor Chief Scientific Officer
CEL-SCI Corporation
Phone: (205) 586-6947
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee See Clinical Protocol Section 13.0 Publication Plan
- Publication restrictions are in place
Restriction type: OTHER