Trial Outcomes & Findings for Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer (NCT NCT00047008)
NCT ID: NCT00047008
Last Updated: 2023-07-07
Results Overview
Overall survival time is defined as time from randomization to the date of death (failure) or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
743 participants
Primary outcome timeframe
From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.
Results posted on
2023-07-07
Participant Flow
Participant milestones
| Measure |
Standard Fractionation RT + Cisplatin
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
|
Accelerated Fractionation RT + Cisplatin
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
|
|---|---|---|
|
Overall Study
STARTED
|
372
|
371
|
|
Overall Study
COMPLETED
|
361
|
360
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
Reasons for withdrawal
| Measure |
Standard Fractionation RT + Cisplatin
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
|
Accelerated Fractionation RT + Cisplatin
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
|
|---|---|---|
|
Overall Study
Withdrawn consent
|
2
|
3
|
|
Overall Study
Ineligible
|
9
|
8
|
Baseline Characteristics
Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Standard Fractionation RT + Cisplatin
n=361 Participants
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
|
Accelerated Fractionation RT + Cisplatin
n=360 Participants
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
|
Total
n=721 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=39 Participants
|
55 years
n=41 Participants
|
56 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=39 Participants
|
72 Participants
n=41 Participants
|
124 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
309 Participants
n=39 Participants
|
288 Participants
n=41 Participants
|
597 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.Population: Eligible patients who did not withdraw consent.
Overall survival time is defined as time from randomization to the date of death (failure) or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Outcome measures
| Measure |
Standard Fractionation RT + Cisplatin
n=361 Participants
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
|
Accelerated Fractionation RT + Cisplatin
n=360 Participants
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
|
|---|---|---|
|
Overall Survival (Percentage of Participants Alive)
|
64.3 percentage of patients
Interval 59.3 to 69.2
|
70.3 percentage of patients
Interval 65.6 to 75.1
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.Population: Eligible patients who did not withdraw consent
Local-regional failure time is defined as time from randomization to persistent disease in the primary tumor or regional nodes (considered an event at day 1), relapse/progression in either of those sites (considered an event at the time of relapse/progression), death (competing event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Outcome measures
| Measure |
Standard Fractionation RT + Cisplatin
n=361 Participants
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
|
Accelerated Fractionation RT + Cisplatin
n=360 Participants
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
|
|---|---|---|
|
Local-regional Failure (Percentage of Participants With Local-regional Failure)
|
25.5 percentage of participants
Interval 21.0 to 30.0
|
28.7 percentage of participants
Interval 24.0 to 33.4
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.Population: Eligible patients who did not withdraw consent
Local-regional failure time is defined as time from randomization to relapse/progression in the primary tumor or regional nodes (event), death due to study cancer or unknown causes (event), death due to other causes (competing event), distant metastasis (competing event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Outcome measures
| Measure |
Standard Fractionation RT + Cisplatin
n=361 Participants
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
|
Accelerated Fractionation RT + Cisplatin
n=360 Participants
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
|
|---|---|---|
|
Local-regional Failure (Alternate Definition) [Percentage of Participants With Local-regional Failure]
|
25.6 percentage of participants
Interval 21.1 to 30.1
|
28.2 percentage of participants
Interval 23.6 to 32.9
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.Population: Eligible patients who did not withdraw consent
Disease-free survival time is defined as time from randomization to persistent disease in the primary tumor or regional nodes (considered an event at day 1), relapse/progression in either of those sites (considered an event at the time of relapse/progression), distant metastasis (event), second primary tumor (event), death (event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Outcome measures
| Measure |
Standard Fractionation RT + Cisplatin
n=361 Participants
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
|
Accelerated Fractionation RT + Cisplatin
n=360 Participants
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
|
|---|---|---|
|
Disease-free Survival (Percentage of Participants Alive Without Disease)
|
51.4 percentage of participants
Interval 46.3 to 56.6
|
53.4 percentage of participants
Interval 48.2 to 58.6
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years. Three-year rates are reported here.Population: Eligible patients who did not withdraw consent
Progression-free survival time is defined as time from randomization to relapse/progression in the primary site or regional nodes (event), distant metastasis (event), death (event), or last follow-up (censored). Progression is defined as an estimated increase in the size of the tumor of greater than 25% or appearance of new areas of malignant disease. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 309 deaths had been reported.
Outcome measures
| Measure |
Standard Fractionation RT + Cisplatin
n=361 Participants
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
|
Accelerated Fractionation RT + Cisplatin
n=360 Participants
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
|
|---|---|---|
|
Progression-free Survival (Alternate Definition of Disease-free Survival) [Percentage of Participants Alive Without Progression]
|
55.8 percentage of participants
Interval 50.6 to 60.9
|
57.0 percentage of participants
Interval 51.8 to 62.1
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Follow-up schedule from end of treatment: 6-8 weeks, every 3 mo. for 2 yr., then every 6 mo. for 3 yr., then yearly. Maximum follow-up at time of analysis was 6.5 years.Population: Eligible patients who did not withdraw consent
Acute radiation therapy toxicities (within 90 days from start of radiation therapy) and systemic effects at any time were scored using Common Toxicity Criteria (CTC) version 2.0. Late RT toxicities (\> 90 days from start of radiation therapy) were scored by the Radiation Therapy Oncology Group (RTOG)/European Organisation for. Research and Treatment of Cancer (EORTC) criteria. Both criteria grades toxicity severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event/toxicity data.
Outcome measures
| Measure |
Standard Fractionation RT + Cisplatin
n=361 Participants
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
|
Accelerated Fractionation RT + Cisplatin
n=360 Participants
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
|
|---|---|---|
|
Percentage of Participants With Toxicity Grade 3 or Higher
Acute
|
83.7 percentage of participants
Interval 79.8 to 87.5
|
80.0 percentage of participants
Interval 75.9 to 84.1
|
|
Percentage of Participants With Toxicity Grade 3 or Higher
Late
|
21.1 percentage of participants
Interval 16.8 to 25.3
|
25.7 percentage of participants
Interval 21.0 to 30.3
|
SECONDARY outcome
Timeframe: Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.Population: Eligible patients who did not withdraw consent, with all 4 assessments: baseline, last 2 weeks of treatment, 3 months, and 12 months.
The PSS-HN is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet (this outcome measure), Public Eating, and Understandability of Speech. Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pre-treatment) and one year calculated by use of area under the curve (AUC).
Outcome measures
| Measure |
Standard Fractionation RT + Cisplatin
n=141 Participants
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
|
Accelerated Fractionation RT + Cisplatin
n=140 Participants
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
|
|---|---|---|
|
Performance Status Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet Score - Area Under the Curve (AUC) at One Year
|
53.36 score on a scale * months
Standard Error 1.99
|
53.63 score on a scale * months
Standard Error 1.97
|
SECONDARY outcome
Timeframe: Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.Population: Eligible patients who did not withdraw consent, with all 4 assessments: baseline, last 2 weeks of treatment, 3 months, and 12 months.
The Performance Status Scale for Head and Neck Cancer (PSS-HN) is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet , Public Eating (this outcome measure), and Understandability of Speech. Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pretreatment) and one year calculated by use of area under the curve (AUC).
Outcome measures
| Measure |
Standard Fractionation RT + Cisplatin
n=126 Participants
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
|
Accelerated Fractionation RT + Cisplatin
n=131 Participants
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
|
|---|---|---|
|
PSS-HN Public Eating Score - AUC at One Year
|
65.81 score on a scale * months
Standard Error 2.18
|
67.10 score on a scale * months
Standard Error 2.12
|
SECONDARY outcome
Timeframe: Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.Population: Eligible patients who did not withdraw consent, with all 4 assessments: baseline, last 2 weeks of treatment, 3 months, and 12 months.
The Performance Status Scale for Head and Neck Cancer (PSS-HN) is a clinician-rated evaluation conducted as an unstructured interview format that assesses three functions: Normalcy of Diet , Public Eating, and Understandability of Speech (this outcome measure). Each function is scored from 0 to 100 and analyzed separately. Higher scores indicate better performance status. Treatment effect was analyzed as time-weighted average between baseline (pretreatment) and one year calculated by use of area under the curve (AUC).
Outcome measures
| Measure |
Standard Fractionation RT + Cisplatin
n=142 Participants
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
|
Accelerated Fractionation RT + Cisplatin
n=145 Participants
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
|
|---|---|---|
|
PSS-HN Understandability of Speech Score - AUC at One Year
|
90.48 score on a scale * months
Standard Error 1.18
|
91.77 score on a scale * months
Standard Error 1.11
|
SECONDARY outcome
Timeframe: Baseline (pretreatment), sometime during the last two weeks of treatment, three months from start of treatment, and one year from start of treatment.Population: Eligible participants who did not withdraw consent, with all 4 assessments: baseline, last 2 weeks of treatment, 3 months, and one year.
The HNRQ is a patient-reported questionnaire administrated through a paper format; it measures radiation-related side effects and the overall well-being of head and neck cancer patients in the past week. The overall score is the mean of the 22 questions, with a range of 1 to 7. Higher scores indicate better quality of life. Treatment effect was analyzed as time-weighted average between baseline (pre-treatment) and 1 year calculated by use of area under the curve (AUC).
Outcome measures
| Measure |
Standard Fractionation RT + Cisplatin
n=139 Participants
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
|
Accelerated Fractionation RT + Cisplatin
n=137 Participants
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
|
|---|---|---|
|
Head and Neck Radiotherapy Questionnaire (HNRQ) - AUC at One Year
|
5.27 score on a scale * months
Standard Error 0.07
|
5.19 score on a scale * months
Standard Error 0.07
|
SECONDARY outcome
Timeframe: From randomization to date of death or last follow-upPopulation: No assays were performed and no data were collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to date of death or last follow-upPopulation: No assays were performed and no data were collected for this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Standard Fractionation RT + Cisplatin
Serious events: 293 serious events
Other events: 360 other events
Deaths: 0 deaths
Accelerated Fractionation RT + Cisplatin
Serious events: 279 serious events
Other events: 356 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Fractionation RT + Cisplatin
n=361 participants at risk
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
|
Accelerated Fractionation RT + Cisplatin
n=360 participants at risk
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.2%
15/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
4.7%
17/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
9.1%
33/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
6.7%
24/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Blood and lymphatic system disorders
Lymphatics-Other
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Blood and lymphatic system disorders
Packed red blood cell transfusion
|
1.9%
7/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
1.9%
7/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Cardiac disorders
Circulatory or cardiac-Other
|
0.55%
2/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Cardiac disorders
Palpitations
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Cardiac disorders
Supraventricular arrhythmia NOS
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Endocrine disorders
Endocrine-Other
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Diarrhea NOS
|
1.9%
7/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Dysphagia
|
22.7%
82/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
21.1%
76/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Esophageal spasm
|
10.2%
37/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
8.6%
31/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Esophagitis NOS
|
8.3%
30/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
13.3%
48/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
GI-other
|
0.83%
3/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.56%
2/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.56%
2/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Ileus
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Late RT Toxicity: Esophagus: NOS
|
7.8%
28/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
10.3%
37/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Late RT Toxicity: Larynx: NOS
|
3.9%
14/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
5.0%
18/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Late RT Toxicity: Mucous Membrane: NOS
|
0.83%
3/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
3.1%
11/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Late RT Toxicity: Other: dysphagia
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Late RT Toxicity: Other: tongue edema
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Nausea
|
19.9%
72/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
14.4%
52/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Pancreatitis NOS
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Radiation mucositis
|
39.1%
141/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
32.5%
117/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Salivary gland disorder NOS
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Stomatitis
|
1.9%
7/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.56%
2/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis for BMT
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Tracheo-oesophageal fistula NOS
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Vomiting NOS
|
18.3%
66/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
11.7%
42/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Fatigue
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.83%
3/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Late RT Toxicity: Other: pain
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Pain due to radiation
|
8.3%
30/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
8.6%
31/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Pain-other
|
2.5%
9/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
1.9%
7/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Culture wound positive
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.56%
2/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Implant infection
|
0.55%
2/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Infection NOS
|
3.6%
13/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
2.2%
8/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Infection with grade 3 or 4 neutropenia
|
1.4%
5/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
3.6%
13/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.56%
2/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Infection, Other
|
1.1%
4/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Injury, poisoning and procedural complications
Dermatitis radiation NOS
|
8.0%
29/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
8.6%
31/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Injury, poisoning and procedural complications
Late RT Toxicity: Subcutaneous Tissue (within XRT field): NOS
|
0.55%
2/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.83%
3/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Blood alkaline phosphatase NOS increased
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Blood creatinine increased
|
4.4%
16/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
2.8%
10/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Cardiac troponin T increased
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Leukopenia NOS
|
3.9%
14/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
3.6%
13/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Lymphopenia
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Metabolic-Other
|
0.55%
2/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Neutropenia
|
4.7%
17/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
3.9%
14/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Platelet count decreased
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Anorexia
|
7.5%
27/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
6.1%
22/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Blood magnesium decreased
|
1.1%
4/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.56%
2/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Dehydration
|
21.1%
76/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
18.6%
67/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.83%
3/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hyperglycemia NOS
|
3.6%
13/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
1.1%
4/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.9%
7/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
1.1%
4/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.1%
4/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.56%
2/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.83%
3/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.83%
3/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
1.4%
5/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.1%
4/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.83%
3/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypoglycaemia NOS
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.8%
28/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
4.7%
17/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.4%
41/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
9.2%
33/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.7%
6/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
1.1%
4/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Joint, muscle, or bone-Other
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Late RT Toxicity: Bone: NOS
|
3.9%
14/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
5.0%
18/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Amnesia NEC
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Dizziness (exc vertigo)
|
1.1%
4/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Headache NOS
|
0.55%
2/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.56%
2/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Hemorrhagic stroke
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Late RT Toxicity: Brain: NOS
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Late RT Toxicity: Spinal Cord: NOS
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Neurologic-Other
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.55%
2/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Syncope
|
1.4%
5/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.83%
3/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Vasovagal attack
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Renal and urinary disorders
Renal failure NOS
|
0.55%
2/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Renal and urinary disorders
Renal/GU-Other
|
1.9%
7/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.83%
3/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Renal and urinary disorders
Urinary retention
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.83%
3/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea NOS
|
0.55%
2/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
1.1%
4/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.56%
2/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Late RT Toxicity: Other: airway obstruction
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Late RT Toxicity: Other: laryngeal hemorrhage
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Late RT Toxicity: Other: pharyngeal bleed
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Late RT Toxicity: Other: stenosis of airway
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Late RT Toxicity: Other: upper airway obstruction
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis NOS
|
1.1%
4/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.56%
2/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-other
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.83%
3/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Vascular disorders
Hemorrhage-Other
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.56%
2/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Vascular disorders
Hypertension NOS
|
0.28%
1/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.00%
0/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Vascular disorders
Hypotension NOS
|
1.7%
6/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
1.9%
7/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Vascular disorders
Late RT Toxicity: Other: arteritis
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Vascular disorders
Thrombosis NOS
|
0.55%
2/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Vascular disorders
Visceral arterial ischaemia
|
0.00%
0/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
0.28%
1/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
Other adverse events
| Measure |
Standard Fractionation RT + Cisplatin
n=361 participants at risk
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
|
Accelerated Fractionation RT + Cisplatin
n=360 participants at risk
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
|
|---|---|---|
|
Psychiatric disorders
Insomnia NEC
|
5.8%
21/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
4.7%
17/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Renal and urinary disorders
Renal/GU-Other
|
11.1%
40/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
6.4%
23/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.8%
28/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
9.2%
33/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
20.8%
75/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
15.3%
55/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.9%
25/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
4.2%
15/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative NOS
|
5.5%
20/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
5.8%
21/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Skin-Other
|
7.5%
27/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
3.3%
12/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Taste disturbance
|
31.6%
114/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
32.5%
117/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Psychiatric disorders
Depression NEC
|
5.8%
21/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
5.6%
20/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
90.0%
325/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
83.6%
301/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Ear and labyrinth disorders
Hearing impaired
|
17.5%
63/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
9.7%
35/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Ear and labyrinth disorders
Hearing-Other
|
14.4%
52/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
14.7%
53/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Constipation
|
20.2%
73/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
15.0%
54/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Diarrhea NOS
|
10.2%
37/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
7.5%
27/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Dry mouth
|
51.0%
184/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
43.3%
156/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Dysphagia
|
31.0%
112/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
26.1%
94/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Esophageal spasm
|
16.1%
58/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
14.4%
52/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Esophagitis NOS
|
32.7%
118/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
28.1%
101/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Late RT Toxicity: Esophagus: NOS
|
40.2%
145/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
42.2%
152/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Late RT Toxicity: Larynx: NOS
|
44.6%
161/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
36.7%
132/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Late RT Toxicity: Mucous Membrane: NOS
|
39.6%
143/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
40.8%
147/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Late RT Toxicity: Salivary Gland (xerostomia, taste impairment)
|
74.8%
270/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
75.3%
271/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Nausea
|
58.2%
210/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
54.7%
197/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Radiation mucositis
|
78.1%
282/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
74.2%
267/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Salivary gland disorder NOS
|
33.2%
120/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
32.2%
116/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Stomatitis
|
8.0%
29/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
5.3%
19/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Vomiting NOS
|
38.8%
140/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
36.4%
131/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Edema NOS
|
3.9%
14/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
5.3%
19/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Fatigue
|
58.7%
212/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
55.0%
198/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Late RT Toxicity: Other: NOS
|
47.9%
173/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
47.5%
171/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Pain due to radiation
|
39.9%
144/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
37.5%
135/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Pain-other
|
12.7%
46/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
11.4%
41/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Pyrexia
|
8.6%
31/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
9.2%
33/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Infection NOS
|
5.8%
21/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
8.3%
30/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Infections and infestations
Infection, Other
|
5.5%
20/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
3.9%
14/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Injury, poisoning and procedural complications
Dermatitis radiation NOS
|
65.4%
236/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
59.2%
213/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Injury, poisoning and procedural complications
Late RT Toxicity: Skin(within RT field): NOS
|
40.2%
145/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
40.3%
145/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Injury, poisoning and procedural complications
Late RT Toxicity: Subcutaneous Tissue (within XRT field): NOS
|
44.0%
159/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
47.5%
171/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Alanine aminotransferase increased
|
8.9%
32/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
9.4%
34/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Aspartate aminotransferase increased
|
7.5%
27/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
8.1%
29/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Blood alkaline phosphatase NOS increased
|
7.5%
27/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
3.6%
13/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Blood creatinine increased
|
33.8%
122/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
23.6%
85/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Leukopenia NOS
|
83.7%
302/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
70.6%
254/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Lymphopenia
|
13.3%
48/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
11.7%
42/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Metabolic-Other
|
7.2%
26/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
7.8%
28/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Neutropenia
|
62.9%
227/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
48.9%
176/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Platelet count decreased
|
28.5%
103/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
24.2%
87/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Weight decreased
|
47.4%
171/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
42.5%
153/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Anorexia
|
26.3%
95/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
20.0%
72/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Blood albumin decreased
|
21.9%
79/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
17.8%
64/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Blood magnesium decreased
|
26.6%
96/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
20.3%
73/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Dehydration
|
46.0%
166/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
30.0%
108/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hyperglycemia NOS
|
18.6%
67/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
15.8%
57/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
13.0%
47/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
6.7%
24/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
19.7%
71/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
14.2%
51/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.3%
84/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
18.6%
67/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
34.9%
126/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
25.6%
92/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Joint, muscle, or bone-Other
|
5.5%
20/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
5.0%
18/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Late RT Toxicity: Bone: NOS
|
6.6%
24/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
8.1%
29/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Late RT Toxicity: Joint: NOS
|
13.3%
48/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
16.4%
59/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Late RT Toxicity: Spinal Cord: NOS
|
4.2%
15/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
5.6%
20/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.2%
55/361
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
8.1%
29/360
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER