Trial Outcomes & Findings for Priming Immunotherapy in Advanced Disease With Radiation (NCT NCT03313804)
NCT ID: NCT03313804
Last Updated: 2026-03-11
Results Overview
Progression-free survival will be calculated as a rate, time from enrollment in the study to progression at 6-months post enrollment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
6-months post enrollment
Results posted on
2026-03-11
Participant Flow
76 participants were enrolled but 1 participant never received treatment and therefore was not counted in the on treatment (started) number.
Participant milestones
| Measure |
Immune Checkpoint Inhibitor + Radiation
Immune checkpoint inhibitor (Nivolumab OR Pembrolizumab OR Atezolizumab) PLUS Radiation Therapy (Stereotactic Body Radiation Therapy OR fractionated radiation therapy)
Immune checkpoint inhibitor: Standard of care immune checkpoint inhibitor
Radiation Therapy: Stereotactic Body Radiation Therapy OR Fractionated radiation therapy
|
|---|---|
|
Treatment
STARTED
|
75
|
|
Treatment
COMPLETED
|
68
|
|
Treatment
NOT COMPLETED
|
7
|
|
Follow Up
STARTED
|
68
|
|
Follow Up
COMPLETED
|
65
|
|
Follow Up
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Immune Checkpoint Inhibitor + Radiation
Immune checkpoint inhibitor (Nivolumab OR Pembrolizumab OR Atezolizumab) PLUS Radiation Therapy (Stereotactic Body Radiation Therapy OR fractionated radiation therapy)
Immune checkpoint inhibitor: Standard of care immune checkpoint inhibitor
Radiation Therapy: Stereotactic Body Radiation Therapy OR Fractionated radiation therapy
|
|---|---|
|
Treatment
Death
|
5
|
|
Treatment
still on treatment
|
2
|
|
Follow Up
still on follow up
|
3
|
Baseline Characteristics
Priming Immunotherapy in Advanced Disease With Radiation
Baseline characteristics by cohort
| Measure |
Immune Checkpoint Inhibitor + Radiation
n=75 Participants
Immune checkpoint inhibitor (Nivolumab OR Pembrolizumab OR Atezolizumab) PLUS Radiation Therapy (Stereotactic Body Radiation Therapy OR fractionated radiation therapy)
Immune checkpoint inhibitor: Standard of care immune checkpoint inhibitor
Radiation Therapy: Stereotactic Body Radiation Therapy OR Fractionated radiation therapy
|
|---|---|
|
Age, Continuous
|
62.51 years
STANDARD_DEVIATION 8.71 • n=9 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 6-months post enrollmentProgression-free survival will be calculated as a rate, time from enrollment in the study to progression at 6-months post enrollment.
Outcome measures
| Measure |
Immune Checkpoint Inhibitor + Radiation
n=67 Participants
Immune checkpoint inhibitor (Nivolumab OR Pembrolizumab OR Atezolizumab) PLUS Radiation Therapy (Stereotactic Body Radiation Therapy OR fractionated radiation therapy)
Immune checkpoint inhibitor: Standard of care immune checkpoint inhibitor
Radiation Therapy: Stereotactic Body Radiation Therapy OR Fractionated radiation therapy
|
|---|---|
|
Proportion of Participants Alive and Without Progression
|
.66 proportion of participants
|
SECONDARY outcome
Timeframe: Assessed at specified points--1) prior to each cycle of therapy for 4 cycles (one cycle equals 6 weeks) 2) at disease progression (date first progression post-randomization, assessed up to 3 years) 3) when participant is off-study, assessed up to 3 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at specified points--1) prior to each cycle of therapy for 4 cycles (one cycle equals 6 weeks) 2) at disease progression (date first progression post-randomization, assessed up to 3 years) 3) when participant is off-study, assessed up to 3 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at specified points--1) prior to each cycle of therapy for 4 cycles (one cycle equals 6 weeks) 2) at disease progression (date first progression post-randomization, assessed up to 3 years) 3) when participant is off-study, assessed up to 3 yearsOutcome measures
Outcome data not reported
Adverse Events
Immune Checkpoint Inhibitor + Radiation
Serious events: 45 serious events
Other events: 72 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Immune Checkpoint Inhibitor + Radiation
n=75 participants at risk
Immune checkpoint inhibitor (Nivolumab OR Pembrolizumab OR Atezolizumab) PLUS Radiation Therapy (Stereotactic Body Radiation Therapy OR fractionated radiation therapy)
Immune checkpoint inhibitor: Standard of care immune checkpoint inhibitor
Radiation Therapy: Stereotactic Body Radiation Therapy OR Fractionated radiation therapy
|
|---|---|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.3%
4/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Lymphocyte count decreased
|
22.7%
17/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Alkaline phosphatase increased
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Alanine aminotransferase increased
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Aspartate aminotransferase increased
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Creatinine increased
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Neutrophil count decreased
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Fatigue
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Edema limbs
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Edema face
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Non-cardiac chest pain
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Disease progression
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Nausea
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Diarrhea
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Anal hemorrhage
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Blood and lymphatic system disorders
Anemia
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Blood and lymphatic system disorders
Other
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Other
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Headache
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Dizziness
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Dysarthria
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Encephalopathy
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Muscle weakness right-sided
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Syncope
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Other
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Lung infection
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Joint infection
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Sepsis
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Psychiatric disorders
Confusion
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Psychiatric disorders
Delirium
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Vascular disorders
Hypotension
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Vascular disorders
Hypertension
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Vascular disorders
Superior vena cava syndrome
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Renal and urinary disorders
Acute kidney injury
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Cardiac disorders
Sinus tachycardia
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Other
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
Other adverse events
| Measure |
Immune Checkpoint Inhibitor + Radiation
n=75 participants at risk
Immune checkpoint inhibitor (Nivolumab OR Pembrolizumab OR Atezolizumab) PLUS Radiation Therapy (Stereotactic Body Radiation Therapy OR fractionated radiation therapy)
Immune checkpoint inhibitor: Standard of care immune checkpoint inhibitor
Radiation Therapy: Stereotactic Body Radiation Therapy OR Fractionated radiation therapy
|
|---|---|
|
Metabolism and nutrition disorders
Hyponatremia
|
37.3%
28/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
32.0%
24/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hypokalemia
|
18.7%
14/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.3%
16/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
17.3%
13/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
17.3%
13/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.7%
8/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.0%
6/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
5/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.3%
4/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Metabolism and nutrition disorders
Other
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Lymphocyte count decreased
|
34.7%
26/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Alkaline phosphatase increased
|
25.3%
19/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Alanine aminotransferase increased
|
14.7%
11/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
10/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Thyroid stimulating hormone increased
|
10.7%
8/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Creatinine increased
|
8.0%
6/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Platelet count decreased
|
8.0%
6/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
White blood cell decreased
|
6.7%
5/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Neutrophil count decreased
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Hemoglobin increased
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Blood bilirubin increased
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Cardiac troponin T increased
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
CPK increased
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Other
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Lymphocyte count increased
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Weight gain
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Weight loss
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Investigations
Urine output decreased
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Fatigue
|
36.0%
27/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Edema limbs
|
10.7%
8/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Edema face
|
6.7%
5/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Pain
|
6.7%
5/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Fever
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Gait disturbance
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Neck edema
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Non-cardiac chest pain
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Chills
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Other
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Facial pain
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
General disorders
Localized edema
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Nausea
|
17.3%
13/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
10/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Dysphagia
|
10.7%
8/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Constipation
|
9.3%
7/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
5/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Dry mouth
|
5.3%
4/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Oral pain
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Mucositis oral
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Abdominal distension
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Bloating
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Colitis
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Esophagitis
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Gastritis
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Other
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Oral dysesthesia
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Gastrointestinal disorders
Small intestinal mucositis
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.7%
14/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.7%
8/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.0%
6/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal mucositis
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.7%
8/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.3%
7/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
6/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
6/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
4/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Other
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
Head soft tissue necrosis
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Blood and lymphatic system disorders
Anemia
|
24.0%
18/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Blood and lymphatic system disorders
Eosinophilia
|
8.0%
6/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.3%
4/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.3%
13/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Other
|
6.7%
5/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
4/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Headache
|
5.3%
4/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.3%
4/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Dizziness
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Dysarthria
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Encephalopathy
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Lethargy
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Muscle weakness right-sided
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Ataxia
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Dysgeusia
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Memory impairment
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Somnolence
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Nervous system disorders
Tremor
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Sinusitis
|
5.3%
4/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Urinary tract infection
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Eye infection
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Other
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Skin infection
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Lung infection
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Papulopustular rash
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Hepatitis viral
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Otitis media
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Rash pustular
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Infections and infestations
Thrush
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Psychiatric disorders
Confusion
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Psychiatric disorders
Insomnia
|
6.7%
5/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Psychiatric disorders
Anxiety
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Psychiatric disorders
Depression
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Psychiatric disorders
Hallucinations
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Vascular disorders
Hypotension
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Vascular disorders
Hypertension
|
4.0%
3/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Vascular disorders
Hot flashes
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Endocrine disorders
Hypothyroidism
|
8.0%
6/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Endocrine disorders
Hyperthyroidism
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Endocrine disorders
Other
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Ear and labyrinth disorders
Other
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Injury, poisoning and procedural complications
Bruising
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Injury, poisoning and procedural complications
Fall
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Injury, poisoning and procedural complications
Other
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Renal and urinary disorders
Dysuria
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Renal and urinary disorders
Urinary retention
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Cardiac disorders
Sinus tachycardia
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Cardiac disorders
Palpitations
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Eye disorders
Dry eye
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Eye disorders
Other
|
1.3%
1/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Reproductive system and breast disorders
Genital edema
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
|
Immune system disorders
Other
|
2.7%
2/75 • 3 years
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place