Trial Outcomes & Findings for Respiratory-gated Stereotactic Body Radiation Therapy for Adenocarcinoma of the Pancreas or Periampullary Region (NCT NCT02780648)
NCT ID: NCT02780648
Last Updated: 2025-11-03
Results Overview
Measures include the percentage of patients who experienced the toxicity with a grade of 3 or higher. Only those adverse events that were related to stereotactic body radiation therapy (SBRT) were considered. Patients were considered at risk for an adverse event if they started SBRT treatment. Toxicities per Common Terminology Criteria for Adverse Events (CTCAE) 4.0.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Up to 90 days after treatment
Results posted on
2025-11-03
Participant Flow
Participant milestones
| Measure |
Cohort A
Patients who have received prior radiation therapy and received Stereotactic Body Radiation Therapy (SBRT) as 5 Gy x 5.
|
Cohort B
Patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
33
|
|
Overall Study
COMPLETED
|
2
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort A
Patients who have received prior radiation therapy and received Stereotactic Body Radiation Therapy (SBRT) as 5 Gy x 5.
|
Cohort B
Patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5
|
|---|---|---|
|
Overall Study
Disease Progression
|
1
|
0
|
Baseline Characteristics
Respiratory-gated Stereotactic Body Radiation Therapy for Adenocarcinoma of the Pancreas or Periampullary Region
Baseline characteristics by cohort
| Measure |
Cohort A
n=3 Participants
Patients who have received prior radiation therapy and received Stereotactic Body Radiation Therapy (SBRT) as 5 Gy x 5.
|
Cohort B
n=33 Participants
Patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 7.2 • n=3 Participants
|
66.5 years
STANDARD_DEVIATION 9.6 • n=15 Participants
|
66.3 years
STANDARD_DEVIATION 9.3 • n=18 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
18 Participants
n=15 Participants
|
20 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
15 Participants
n=15 Participants
|
16 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=3 Participants
|
31 Participants
n=15 Participants
|
33 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
2 Participants
n=15 Participants
|
2 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants
|
4 Participants
n=15 Participants
|
4 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=3 Participants
|
27 Participants
n=15 Participants
|
30 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
2 Participants
n=15 Participants
|
2 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=3 Participants
|
33 Participants
n=15 Participants
|
36 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Up to 90 days after treatmentPopulation: Includes all patients in cohorts A and B who met eligibility criteria for primary outcome measure.
Measures include the percentage of patients who experienced the toxicity with a grade of 3 or higher. Only those adverse events that were related to stereotactic body radiation therapy (SBRT) were considered. Patients were considered at risk for an adverse event if they started SBRT treatment. Toxicities per Common Terminology Criteria for Adverse Events (CTCAE) 4.0.
Outcome measures
| Measure |
All Eligible Participants
n=36 Participants
The two cohorts were combined since the safety profile was expected to be similar.
Cohort A included patients who have received prior radiation therapy and received Stereotactic Body Radiation Therapy (SBRT) as 5 Gy x 5. Cohort B included patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5.
|
Cohort B
Patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5
|
|---|---|---|
|
Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage)
Hematologic: Lymphocyte Count Decreased
|
13.89 percentage of participants
Interval 4.41 to 23.37
|
—
|
|
Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage)
Hematologic: White Blood Cell Decreased
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
—
|
|
Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage)
Gastrointestinal: Nausea
|
2.78 percentage of participants
Interval 0.0 to 7.28
|
—
|
|
Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage)
Gastrointestinal: Abdominal Pain
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
—
|
|
Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage)
Gastrointestinal: Diarrhea
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
—
|
|
Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage)
Gastrointestinal: Bloating
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
—
|
|
Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage)
Gastrointestinal: Flatulence
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
—
|
|
Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage)
Gastrointestinal: Gastritis
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
—
|
|
Acute Toxicity Rates of Grade 3 or Greater Gastrointestinal and Hematologic Toxicities (as Raw Percentage)
Gastrointestinal: Vomiting
|
2.78 percentage of participants
Interval 0.0 to 7.28
|
—
|
SECONDARY outcome
Timeframe: 90 or more days after treatment, up to 7 yearsPopulation: Includes those patients who were determined to be eligible for the secondary outcome measures.
Measures include the percentage of patients who experienced the toxicity with a grade of 2 or higher. Only those adverse events that were related to stereotactic body radiation therapy (SBRT) were considered. Patients were considered at risk for an adverse event if they started SBRT treatment. Toxicities per Common Terminology Criteria for Adverse Events (CTCAE) 4.0.
Outcome measures
| Measure |
All Eligible Participants
n=36 Participants
The two cohorts were combined since the safety profile was expected to be similar.
Cohort A included patients who have received prior radiation therapy and received Stereotactic Body Radiation Therapy (SBRT) as 5 Gy x 5. Cohort B included patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5.
|
Cohort B
Patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5
|
|---|---|---|
|
Late, Treatment-related Toxicity Rates of Gastritis, Enteritis, Fistula, and Ulcer, or Any Other Gastrointestinal Toxicity (as Raw Percentage)
Gastritis
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
—
|
|
Late, Treatment-related Toxicity Rates of Gastritis, Enteritis, Fistula, and Ulcer, or Any Other Gastrointestinal Toxicity (as Raw Percentage)
Enteritis
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
—
|
|
Late, Treatment-related Toxicity Rates of Gastritis, Enteritis, Fistula, and Ulcer, or Any Other Gastrointestinal Toxicity (as Raw Percentage)
Fistula
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
—
|
|
Late, Treatment-related Toxicity Rates of Gastritis, Enteritis, Fistula, and Ulcer, or Any Other Gastrointestinal Toxicity (as Raw Percentage)
Ulcer
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
—
|
|
Late, Treatment-related Toxicity Rates of Gastritis, Enteritis, Fistula, and Ulcer, or Any Other Gastrointestinal Toxicity (as Raw Percentage)
Diarrhea
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
—
|
|
Late, Treatment-related Toxicity Rates of Gastritis, Enteritis, Fistula, and Ulcer, or Any Other Gastrointestinal Toxicity (as Raw Percentage)
Vomiting
|
0.00 percentage of participants
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: 1 year after treatmentPopulation: Includes patients in Cohort B who were considered eligible for the outcome analyses.
This measure reports the overall survival probability from the Kaplan Meier method. The survival time was calculated from the date of treatment start to the date of death and patients who did not expire were censored at their last date known alive.
Outcome measures
| Measure |
All Eligible Participants
The two cohorts were combined since the safety profile was expected to be similar.
Cohort A included patients who have received prior radiation therapy and received Stereotactic Body Radiation Therapy (SBRT) as 5 Gy x 5. Cohort B included patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5.
|
Cohort B
n=33 Participants
Patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5
|
|---|---|---|
|
Overall Survival
|
—
|
.4849 survival probability
Interval 0.3368 to 0.6178
|
SECONDARY outcome
Timeframe: 1 year after treatmentPopulation: Includes patients in cohort B who were determined to be eligible for the secondary objectives.
This measure represents the progression-free survival at one-year following treatment start. The survival time was calculated from the date of treatment start to the date of progression or death. Patients who did not experience progression were censored at their last known date alive.
Outcome measures
| Measure |
All Eligible Participants
The two cohorts were combined since the safety profile was expected to be similar.
Cohort A included patients who have received prior radiation therapy and received Stereotactic Body Radiation Therapy (SBRT) as 5 Gy x 5. Cohort B included patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5.
|
Cohort B
n=33 Participants
Patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5
|
|---|---|---|
|
Progression-Free Survival
|
—
|
.3939 survival probability
Interval 0.2557 to 0.5293
|
SECONDARY outcome
Timeframe: 1 year after treatmentPopulation: Includes patients in Cohort B who were determined to be eligible for the secondary outcomes analyses.
This represents the metastasis-free survival at one-year following treatment start. The survival time was calculated from the date of treatment start to the date of metastasis or death. Patients who did not experience metastasis or death were censored at their last known date alive.
Outcome measures
| Measure |
All Eligible Participants
The two cohorts were combined since the safety profile was expected to be similar.
Cohort A included patients who have received prior radiation therapy and received Stereotactic Body Radiation Therapy (SBRT) as 5 Gy x 5. Cohort B included patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5.
|
Cohort B
n=33 Participants
Patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5
|
|---|---|---|
|
Metastasis-Free Survival
|
—
|
.4846 survival probability
Interval 0.3368 to 0.6178
|
SECONDARY outcome
Timeframe: Baseline (before treatment), Week 1 (during treatment), Week 2 (during treatment), Month 1 (after treatment), and Month 3 (after treatment)Population: Includes all patients who were determined to be eligible for the secondary outcomes.
Measured with the Wong-Baker FACES 0-10 scale where higher scores indicate more pain. Patients self-reported the score before (baseline), during (weeks 1 and 2), and after (1 and 3 months) treatment. Scores collected during treatment (weeks 1 and 2) were averaged to create a composite "during treatment" score. Similarly, scores collected after treatment (months 1 and 3) were averaged to create a composite "after treatment" score.
Outcome measures
| Measure |
All Eligible Participants
n=3 Participants
The two cohorts were combined since the safety profile was expected to be similar.
Cohort A included patients who have received prior radiation therapy and received Stereotactic Body Radiation Therapy (SBRT) as 5 Gy x 5. Cohort B included patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5.
|
Cohort B
n=33 Participants
Patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5
|
|---|---|---|
|
Wong-Baker FACES Pain Rating Score
Before Treatment Score
|
1.00 score on a scale
Interval 0.0 to 2.5
|
2.00 score on a scale
Interval 0.0 to 4.0
|
|
Wong-Baker FACES Pain Rating Score
During Treatment Score
|
2.00 score on a scale
Interval 1.0 to 2.0
|
0.00 score on a scale
Interval 0.0 to 2.0
|
|
Wong-Baker FACES Pain Rating Score
After Treatment Score
|
2.00 score on a scale
Interval 0.0 to 2.0
|
0.00 score on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline (before treatment), 1 week (during treatment), 2 weeks (during treatment), 1 month (after treatment), 3 months (after treatment), 6 months (after treatment), 9 months (after treatment), and 12 months (after treatment)Population: Includes patients who were eligible for the secondary outcomes.
Patients completed the EORTC Quality of Life (QOL)-Q (QLQ-C30 Version 3) questionnaire before treatment, during treatment, and after treatment. The questionnaire includes 30 questions to assess the quality of life in cancer patients. The Global Health Status / Quality of Life composite score was calculated by combining the scores for questions 29 and 30 and calculating Score = {(RS -1) range}×100. Responses for questions 29 and 30 ranged from 1 to 7 with 1 indicating "Very Poor" and 7 indicating "Excellent". Higher scores indicate a better quality of life with a minimum composite score of 0 and a maximum composite score of 100. Scores collected during treatment (weeks 1 and 2) were averaged to create a composite "during treatment" score. Similarly, scores collected after treatment (months 1, 3, 6, 9, and 12) were averaged to create a composite "after treatment" score.
Outcome measures
| Measure |
All Eligible Participants
n=3 Participants
The two cohorts were combined since the safety profile was expected to be similar.
Cohort A included patients who have received prior radiation therapy and received Stereotactic Body Radiation Therapy (SBRT) as 5 Gy x 5. Cohort B included patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5.
|
Cohort B
n=33 Participants
Patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5
|
|---|---|---|
|
Quality of Life Scores - Global Health Status / Quality of Life
Global Health Status - Before Treatment
|
83.33 score on a scale
Interval 83.33 to 83.33
|
75.00 score on a scale
Interval 50.0 to 83.33
|
|
Quality of Life Scores - Global Health Status / Quality of Life
Global Health Status - During Treatment
|
83.33 score on a scale
Interval 83.33 to 83.33
|
66.67 score on a scale
Interval 50.0 to 83.33
|
|
Quality of Life Scores - Global Health Status / Quality of Life
Global Health Status - After Treatment
|
79.17 score on a scale
Interval 43.75 to 83.33
|
70.83 score on a scale
Interval 50.0 to 83.33
|
SECONDARY outcome
Timeframe: Baseline (before treatment), 1 week (during treatment), 2 weeks (during treatment), 1 month (after treatment), 3 months (after treatment), 6 months (after treatment), 9 months (after treatment), and 12 months (after treatment)Population: Includes patients who were eligible for the secondary outcomes.
Patients completed the EORTC Quality of Life (QOL)-Q (QLQ-C30 Version 3) questionnaire before treatment, during treatment, and after treatment. The questionnaire includes 30 questions to assess the quality of life in cancer patients. The Functional scales composite scores were calculated by combining the scores for the relevant questions and calculating Score = {1 - ((RS -1) / range)}×100. The response options for each question were "1-Not at all", "2-A little", "3-Quite a bit", and "4-Very Much". Higher scores indicate a high/healthy level of functioning with a minimum composite score of 0 and a maximum composite score of 100. In each category, scores collected during treatment (weeks 1 and 2) were averaged to create a composite "during treatment" score. Similarly, scores collected after treatment (months 1, 3, 6, 9, and 12) were averaged to create a composite "after treatment" score.
Outcome measures
| Measure |
All Eligible Participants
n=3 Participants
The two cohorts were combined since the safety profile was expected to be similar.
Cohort A included patients who have received prior radiation therapy and received Stereotactic Body Radiation Therapy (SBRT) as 5 Gy x 5. Cohort B included patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5.
|
Cohort B
n=33 Participants
Patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5
|
|---|---|---|
|
Quality of Life Scores - Functional Scales
Cognitive Functioning - After Treatment
|
83.33 score on a scale
Interval 70.83 to 95.83
|
83.33 score on a scale
Interval 79.17 to 100.0
|
|
Quality of Life Scores - Functional Scales
Physical Functioning - Before Treatment
|
76.67 score on a scale
Interval 71.67 to 81.67
|
93.33 score on a scale
Interval 86.67 to 100.0
|
|
Quality of Life Scores - Functional Scales
Physical Functioning - During Treatment
|
86.67 score on a scale
Interval 86.67 to 88.33
|
86.67 score on a scale
Interval 73.33 to 93.33
|
|
Quality of Life Scores - Functional Scales
Physical Functioning - After Treatment
|
80.00 score on a scale
Interval 73.33 to 96.67
|
86.67 score on a scale
Interval 80.0 to 100.0
|
|
Quality of Life Scores - Functional Scales
Role Functioning - Before Treatment
|
50.00 score on a scale
Interval 41.67 to 58.33
|
83.33 score on a scale
Interval 66.67 to 100.0
|
|
Quality of Life Scores - Functional Scales
Role Functioning - During Treatment
|
75.00 score on a scale
Interval 66.67 to 83.33
|
83.33 score on a scale
Interval 66.67 to 100.0
|
|
Quality of Life Scores - Functional Scales
Role Functioning - After Treatment
|
75.00 score on a scale
Interval 41.67 to 95.83
|
100.00 score on a scale
Interval 66.67 to 100.0
|
|
Quality of Life Scores - Functional Scales
Emotional Functioning - Before Treatment
|
75.00 score on a scale
Interval 70.83 to 79.17
|
83.33 score on a scale
Interval 66.67 to 91.67
|
|
Quality of Life Scores - Functional Scales
Emotional Functioning - During Treatment
|
83.33 score on a scale
Interval 81.25 to 83.33
|
91.67 score on a scale
Interval 75.0 to 100.0
|
|
Quality of Life Scores - Functional Scales
Emotional Functioning - After Treatment
|
75.00 score on a scale
Interval 68.75 to 81.25
|
83.33 score on a scale
Interval 72.92 to 100.0
|
|
Quality of Life Scores - Functional Scales
Cognitive Functioning - Before Treatment
|
91.67 score on a scale
Interval 87.5 to 95.83
|
83.33 score on a scale
Interval 66.67 to 100.0
|
|
Quality of Life Scores - Functional Scales
Cognitive Functioning - During Treatment
|
100.00 score on a scale
Interval 100.0 to 100.0
|
83.33 score on a scale
Interval 83.33 to 100.0
|
|
Quality of Life Scores - Functional Scales
Social Functioning - Before Treatment
|
33.33 score on a scale
Interval 33.33 to 33.33
|
66.67 score on a scale
Interval 50.0 to 83.33
|
|
Quality of Life Scores - Functional Scales
Social Functioning - During Treatment
|
83.33 score on a scale
Interval 62.5 to 100.0
|
66.67 score on a scale
Interval 50.0 to 100.0
|
|
Quality of Life Scores - Functional Scales
Social Functioning - After Treatment
|
66.67 score on a scale
Interval 54.17 to 91.67
|
83.33 score on a scale
Interval 66.67 to 100.0
|
SECONDARY outcome
Timeframe: Baseline (before treatment), 1 week (during treatment), 2 weeks (during treatment), 1 month (after treatment), 3 months (after treatment), 6 months (after treatment), 9 months (after treatment), and 12 months (after treatment)Population: Includes patients who were eligible for the secondary outcomes.
Patients completed the EORTC Quality of Life (QOL)-Q (QLQ-C30 Version 3) questionnaire before treatment, during treatment, and after treatment. The questionnaire includes 30 questions to assess the quality of life in cancer patients. The Symptom scales composite scores were calculated by combining the scores for the relevant questions and calculating Score = {(RS -1) range}×100. The response options for each question were "1-Not at all", "2-A little", "3-Quite a bit", and "4-Very Much". Higher scores indicate a high level of symptomatology / problems with a minimum composite score of 0 and a maximum composite score of 100. In each category, scores collected during treatment (weeks 1 and 2) were averaged to create a composite "during treatment" score. Similarly, scores collected after treatment (months 1, 3, 6, 9, and 12) were averaged to create a composite "after treatment" score.
Outcome measures
| Measure |
All Eligible Participants
n=3 Participants
The two cohorts were combined since the safety profile was expected to be similar.
Cohort A included patients who have received prior radiation therapy and received Stereotactic Body Radiation Therapy (SBRT) as 5 Gy x 5. Cohort B included patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5.
|
Cohort B
n=33 Participants
Patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5
|
|---|---|---|
|
Quality of Life Scores - Symptom Scales
Pain - Before Treatment
|
41.67 score on a scale
Interval 37.5 to 45.83
|
16.67 score on a scale
Interval 0.0 to 33.33
|
|
Quality of Life Scores - Symptom Scales
Pain - During Treatment
|
16.67 score on a scale
Interval 16.67 to 20.83
|
33.33 score on a scale
Interval 0.0 to 50.0
|
|
Quality of Life Scores - Symptom Scales
Pain - After Treatment
|
33.33 score on a scale
Interval 20.83 to 58.33
|
16.67 score on a scale
Interval 0.0 to 50.0
|
|
Quality of Life Scores - Symptom Scales
Constipation - During Treatment
|
0.00 score on a scale
Interval 0.0 to 8.33
|
16.67 score on a scale
Interval 0.0 to 33.33
|
|
Quality of Life Scores - Symptom Scales
Fatigue - Before Treatment
|
44.44 score on a scale
Interval 33.33 to 55.56
|
33.33 score on a scale
Interval 25.0 to 44.44
|
|
Quality of Life Scores - Symptom Scales
Fatigue - During Treatment
|
33.33 score on a scale
Interval 33.33 to 33.33
|
33.33 score on a scale
Interval 22.22 to 55.56
|
|
Quality of Life Scores - Symptom Scales
Fatigue - After Treatment
|
44.44 score on a scale
Interval 33.33 to 72.22
|
33.33 score on a scale
Interval 11.11 to 44.44
|
|
Quality of Life Scores - Symptom Scales
Nausea and Vomiting - Before Treatment
|
0.00 score on a scale
Interval 0.0 to 0.0
|
0.00 score on a scale
Interval 0.0 to 16.67
|
|
Quality of Life Scores - Symptom Scales
Nausea and Vomiting - During Treatment
|
8.33 score on a scale
Interval 0.0 to 16.67
|
16.67 score on a scale
Interval 0.0 to 16.67
|
|
Quality of Life Scores - Symptom Scales
Nausea and Vomiting - After Treatment
|
25.00 score on a scale
Interval 16.67 to 33.33
|
0.00 score on a scale
Interval 0.0 to 16.67
|
|
Quality of Life Scores - Symptom Scales
Dyspnea - Before Treatment
|
16.67 score on a scale
Interval 8.33 to 25.0
|
0.00 score on a scale
Interval 0.0 to 0.0
|
|
Quality of Life Scores - Symptom Scales
Dyspnea - During Treatment
|
0.00 score on a scale
Interval 0.0 to 0.0
|
0.00 score on a scale
Interval 0.0 to 0.0
|
|
Quality of Life Scores - Symptom Scales
Dyspnea - After Treatment
|
0.00 score on a scale
Interval 0.0 to 0.0
|
0.00 score on a scale
Interval 0.0 to 33.33
|
|
Quality of Life Scores - Symptom Scales
Insomnia - Before Treatment
|
33.33 score on a scale
Interval 16.67 to 50.0
|
33.33 score on a scale
Interval 0.0 to 33.33
|
|
Quality of Life Scores - Symptom Scales
Insomnia - During Treatment
|
0.00 score on a scale
Interval 0.0 to 0.0
|
0.00 score on a scale
Interval 0.0 to 33.33
|
|
Quality of Life Scores - Symptom Scales
Insomnia - After Treatment
|
16.67 score on a scale
Interval 0.0 to 33.33
|
0.00 score on a scale
Interval 0.0 to 33.33
|
|
Quality of Life Scores - Symptom Scales
Appetite Loss - Before Treatment
|
16.67 score on a scale
Interval 8.33 to 25.0
|
0.00 score on a scale
Interval 0.0 to 33.33
|
|
Quality of Life Scores - Symptom Scales
Appetite Loss - During Treatment
|
0.00 score on a scale
Interval 0.0 to 0.0
|
0.00 score on a scale
Interval 0.0 to 33.33
|
|
Quality of Life Scores - Symptom Scales
Appetite Loss - After Treatment
|
16.67 score on a scale
Interval 0.0 to 58.33
|
0.00 score on a scale
Interval 0.0 to 33.33
|
|
Quality of Life Scores - Symptom Scales
Constipation - Before Treatment
|
0.00 score on a scale
Interval 0.0 to 0.0
|
0.00 score on a scale
Interval 0.0 to 33.33
|
|
Quality of Life Scores - Symptom Scales
Constipation - After Treatment
|
0.00 score on a scale
Interval 0.0 to 25.0
|
0.00 score on a scale
Interval 0.0 to 0.0
|
|
Quality of Life Scores - Symptom Scales
Diarrhea - Before Treatment
|
0.00 score on a scale
Interval 0.0 to 0.0
|
16.67 score on a scale
Interval 0.0 to 33.33
|
|
Quality of Life Scores - Symptom Scales
Diarrhea - During Treatment
|
16.67 score on a scale
Interval 0.0 to 33.33
|
0.00 score on a scale
Interval 0.0 to 33.33
|
|
Quality of Life Scores - Symptom Scales
Diarrhea - After Treatment
|
16.67 score on a scale
Interval 0.0 to 33.33
|
33.33 score on a scale
Interval 0.0 to 33.33
|
|
Quality of Life Scores - Symptom Scales
Financial Difficulties - Before Treatment
|
66.67 score on a scale
Interval 66.67 to 66.67
|
33.33 score on a scale
Interval 0.0 to 66.67
|
|
Quality of Life Scores - Symptom Scales
Financial Difficulties - During Treatment
|
16.67 score on a scale
Interval 0.0 to 33.33
|
33.33 score on a scale
Interval 0.0 to 66.67
|
|
Quality of Life Scores - Symptom Scales
Financial Difficulties - After Treatment
|
33.33 score on a scale
Interval 8.33 to 58.33
|
33.33 score on a scale
Interval 0.0 to 33.33
|
Adverse Events
Cohort A
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort B
Serious events: 33 serious events
Other events: 24 other events
Deaths: 33 deaths
Serious adverse events
| Measure |
Cohort A
n=3 participants at risk
Patients who have received prior radiation therapy and received Stereotactic Body Radiation Therapy (SBRT) as 5 Gy x 5.
|
Cohort B
n=33 participants at risk
Patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • 7 years from start of treatment
|
0.00%
0/33 • 7 years from start of treatment
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, sp
|
33.3%
1/3 • 7 years from start of treatment
|
6.1%
2/33 • 7 years from start of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • 7 years from start of treatment
|
6.1%
2/33 • 7 years from start of treatment
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • 7 years from start of treatment
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • 7 years from start of treatment
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • 7 years from start of treatment
|
12.1%
4/33 • 7 years from start of treatment
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • 7 years from start of treatment
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • 7 years from start of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • 7 years from start of treatment
|
|
Infections and infestations
Duodenal infection
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • 7 years from start of treatment
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • 7 years from start of treatment
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • 7 years from start of treatment
|
|
General disorders and administration site conditions
Fever
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • 7 years from start of treatment
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • 7 years from start of treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • 7 years from start of treatment
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • 7 years from start of treatment
|
|
General disorders and administration site conditions
Hypothermia
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • 7 years from start of treatment
|
|
Investigations
INR increased
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • 7 years from start of treatment
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • 7 years from start of treatment
|
|
General disorders and administration site conditions
Pain
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • 7 years from start of treatment
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • 7 years from start of treatment
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • 7 years from start of treatment
|
Other adverse events
| Measure |
Cohort A
n=3 participants at risk
Patients who have received prior radiation therapy and received Stereotactic Body Radiation Therapy (SBRT) as 5 Gy x 5.
|
Cohort B
n=33 participants at risk
Patients with no history of prior radiation treatment and who received SBRT as 6.6 Gy x 5
|
|---|---|---|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • 7 years from start of treatment
|
15.2%
5/33 • Number of events 6 • 7 years from start of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 2 • 7 years from start of treatment
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
33.3%
1/3 • Number of events 1 • 7 years from start of treatment
|
0.00%
0/33 • 7 years from start of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 7 years from start of treatment
|
9.1%
3/33 • Number of events 5 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 7 years from start of treatment
|
30.3%
10/33 • Number of events 13 • 7 years from start of treatment
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 2 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
General disorders and administration site conditions
Edema limbs
|
0.00%
0/3 • 7 years from start of treatment
|
15.2%
5/33 • Number of events 5 • 7 years from start of treatment
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
General disorders and administration site conditions
Fatigue
|
66.7%
2/3 • Number of events 2 • 7 years from start of treatment
|
51.5%
17/33 • Number of events 22 • 7 years from start of treatment
|
|
General disorders and administration site conditions
Fever
|
33.3%
1/3 • Number of events 1 • 7 years from start of treatment
|
18.2%
6/33 • Number of events 6 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • Number of events 2 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 2 • 7 years from start of treatment
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 2 • 7 years from start of treatment
|
|
General disorders and administration site conditions
Gait disturbance
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 2 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/3 • 7 years from start of treatment
|
9.1%
3/33 • Number of events 3 • 7 years from start of treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 2 • 7 years from start of treatment
|
|
Psychiatric disorders
Hallucinations
|
33.3%
1/3 • Number of events 1 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 3 • 7 years from start of treatment
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 2 • 7 years from start of treatment
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 5 • 7 years from start of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • 7 years from start of treatment
|
15.2%
5/33 • Number of events 6 • 7 years from start of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • 7 years from start of treatment
|
15.2%
5/33 • Number of events 7 • 7 years from start of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • 7 years from start of treatment
|
12.1%
4/33 • Number of events 5 • 7 years from start of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
General disorders and administration site conditions
Hypothermia
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Investigations
INR increased
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 3 • 7 years from start of treatment
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Investigations
Investigations - Other, specify
|
33.3%
1/3 • Number of events 1 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 5 • 7 years from start of treatment
|
|
Nervous system disorders
Lethargy
|
33.3%
1/3 • Number of events 1 • 7 years from start of treatment
|
0.00%
0/33 • 7 years from start of treatment
|
|
General disorders and administration site conditions
Localized edema
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 2 • 7 years from start of treatment
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 4 • 7 years from start of treatment
|
48.5%
16/33 • Number of events 26 • 7 years from start of treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 2 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 3 • 7 years from start of treatment
|
36.4%
12/33 • Number of events 17 • 7 years from start of treatment
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 2 • 7 years from start of treatment
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • 7 years from start of treatment
|
9.1%
3/33 • Number of events 5 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
General disorders and administration site conditions
Pain
|
0.00%
0/3 • 7 years from start of treatment
|
9.1%
3/33 • Number of events 6 • 7 years from start of treatment
|
|
Investigations
Pancreatic enzymes decreased
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 3 • 7 years from start of treatment
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Number of events 1 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Nervous system disorders
Presyncope
|
33.3%
1/3 • Number of events 1 • 7 years from start of treatment
|
0.00%
0/33 • 7 years from start of treatment
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • 7 years from start of treatment
|
18.2%
6/33 • Number of events 8 • 7 years from start of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 2 • 7 years from start of treatment
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 2 • 7 years from start of treatment
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 2 • 7 years from start of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Investigations
Urine output decreased
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • 7 years from start of treatment
|
12.1%
4/33 • Number of events 7 • 7 years from start of treatment
|
|
Investigations
Weight gain
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Investigations
Weight loss
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • 7 years from start of treatment
|
18.2%
6/33 • Number of events 12 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • 7 years from start of treatment
|
12.1%
4/33 • Number of events 4 • 7 years from start of treatment
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • Number of events 2 • 7 years from start of treatment
|
60.6%
20/33 • Number of events 39 • 7 years from start of treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 2 • 7 years from start of treatment
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 7 years from start of treatment
|
39.4%
13/33 • Number of events 22 • 7 years from start of treatment
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • 7 years from start of treatment
|
24.2%
8/33 • Number of events 11 • 7 years from start of treatment
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 2 • 7 years from start of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • 7 years from start of treatment
|
36.4%
12/33 • Number of events 24 • 7 years from start of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 2 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • 7 years from start of treatment
|
12.1%
4/33 • Number of events 10 • 7 years from start of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 7 years from start of treatment
|
45.5%
15/33 • Number of events 24 • 7 years from start of treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • 7 years from start of treatment
|
24.2%
8/33 • Number of events 8 • 7 years from start of treatment
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 2 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Bloating
|
33.3%
1/3 • Number of events 2 • 7 years from start of treatment
|
15.2%
5/33 • Number of events 5 • 7 years from start of treatment
|
|
Eye disorders
Blurred vision
|
33.3%
1/3 • Number of events 1 • 7 years from start of treatment
|
0.00%
0/33 • 7 years from start of treatment
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/3 • 7 years from start of treatment
|
6.1%
2/33 • Number of events 4 • 7 years from start of treatment
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • 7 years from start of treatment
|
30.3%
10/33 • Number of events 20 • 7 years from start of treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 2 • 7 years from start of treatment
|
|
Investigations
CPK increased
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
General disorders and administration site conditions
Chills
|
33.3%
1/3 • Number of events 1 • 7 years from start of treatment
|
9.1%
3/33 • Number of events 3 • 7 years from start of treatment
|
|
Nervous system disorders
Cognitive disturbance
|
33.3%
1/3 • Number of events 1 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • 7 years from start of treatment
|
3.0%
1/33 • Number of events 1 • 7 years from start of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place