Trial Outcomes & Findings for Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer (NCT NCT01266460)
NCT ID: NCT01266460
Last Updated: 2020-09-11
Results Overview
Number of patients with dose-limiting toxicities, as assessed by CTCAE v 4.0
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
28 days
Results posted on
2020-09-11
Participant Flow
GOG-0265 enrolled 54 patients from May 23, 2011 to September of 2015. Of the 54 patients enrolled, 50 patients received treatment.
Participant milestones
| Measure |
Treatment (ADXS11-001)
Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
Treatment (ADXS11-001)
Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Disease Progression
|
18
|
|
Overall Study
Not otherwise specified
|
8
|
Baseline Characteristics
Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer
Baseline characteristics by cohort
| Measure |
Treatment (ADXS11-001)
n=50 Participants
Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Age, Customized
20 - 29 years
|
25 Participants
n=5 Participants
|
|
Age, Customized
30 - 39 years
|
11 Participants
n=5 Participants
|
|
Age, Customized
40 - 49 years
|
17 Participants
n=5 Participants
|
|
Age, Customized
50 - 59 years
|
9 Participants
n=5 Participants
|
|
Age, Customized
60 - 69 years
|
10 Participants
n=5 Participants
|
|
Age, Customized
70 - 79 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
>= 80 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Only the first six patients were analyzed for Dose Limiting Toxicities.
Number of patients with dose-limiting toxicities, as assessed by CTCAE v 4.0
Outcome measures
| Measure |
Treatment (ADXS11-001)
n=6 Participants
Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Number of Patients With Dose-limiting Toxicities, as Assessed by CTCAE v 4.0
|
0 Participants
|
PRIMARY outcome
Timeframe: Adverse events were collected an average of 4 years 7 monthsPopulation: Eligible and evaluable.
Incidence of adverse effects as assessed by CTCAE v 4.0 (i.e. the number of patients experiencing at least one grade 3 adverse event)
Outcome measures
| Measure |
Treatment (ADXS11-001)
n=50 Participants
Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Incidence of Adverse Effects as Assessed by CTCAE v 4.0
|
29 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Eligible and evaluable
The number of patients (and percentage) who survive for at least 12 months.
Outcome measures
| Measure |
Treatment (ADXS11-001)
n=50 Participants
Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Number of Patients Who Survive for at Least 12 Months
|
19 Participants
|
SECONDARY outcome
Timeframe: Patients will be followed (physical exams and histories) every three months for the first three years, then every six months for the next two years. Patients will be monitored for delayed toxicity and survival for 5-year period, unless consent withdrawn.Population: Eligible and evaluable.
Characterized with Kaplan-Meier plots and estimates of the median time until death.
Outcome measures
| Measure |
Treatment (ADXS11-001)
n=50 Participants
Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Distribution of Overall Survival
|
6.1 Months
Interval 4.3 to 12.1
|
SECONDARY outcome
Timeframe: Patients will be followed (physical exams and histories) every three months for the first three years, then every six months for the next two years. Patients will be monitored for delayed toxicity and survival for 5-year period, unless consent withdrawn.Population: Eligible and evaluable
Characterized with Kaplan-Meier plots and estimates of the median time until progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Treatment (ADXS11-001)
n=50 Participants
Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Distribution of Progression-free Survival
|
2.8 Months
Interval 2.6 to 3.0
|
SECONDARY outcome
Timeframe: Patients will be followed (physical exams and histories) every three months for the first three years, then every six months for the next two years. Patients will be monitored for delayed toxicity and survival for 5-year period, unless consent withdrawn.Population: Eligible and evaluable.
The number of patients who have objective tumor response (complete response or partial response). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (ADXS11-001)
n=50 Participants
Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Number of Patients Who Have Objective Tumor Response (Complete or Partial)
Complete Response
|
0 Participants
|
|
Number of Patients Who Have Objective Tumor Response (Complete or Partial)
Partial Response
|
2 Participants
|
|
Number of Patients Who Have Objective Tumor Response (Complete or Partial)
Stable Disease
|
5 Participants
|
|
Number of Patients Who Have Objective Tumor Response (Complete or Partial)
Progressive Disease
|
32 Participants
|
|
Number of Patients Who Have Objective Tumor Response (Complete or Partial)
Not Evaluable
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 24 hours after dose 3Examined with descriptive statistics and graphics, and their relationship with survival and tumor response will be examined with proportional hazards and logistic regression models, as appropriate.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (ADXS11-001)
Serious events: 27 serious events
Other events: 50 other events
Deaths: 43 deaths
Serious adverse events
| Measure |
Treatment (ADXS11-001)
n=50 participants at risk
Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.0%
3/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Investigations
Alkaline phosphatase increased
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Ascites
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Investigations
Blood bilirubin increased
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
General disorders
Chills
|
6.0%
3/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Psychiatric disorders
Confusion
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Constipation
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Investigations
Creatinine increased
|
8.0%
4/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Immune system disorders
Cytokine release syndrome
|
12.0%
6/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Psychiatric disorders
Delirium
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
General disorders
Fatigue
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
General disorders
Fever
|
6.0%
3/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Vascular disorders
Flushing
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Investigations
GGT increased
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Hepatobiliary disorders
Hepatic failure
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Vascular disorders
Hypotension
|
12.0%
6/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Investigations
INR increased
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Nervous system disorders
Lethargy
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Infections and infestations
Lung infection
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
General disorders
Malaise
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
General disorders
Pain
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Infections and infestations
Sepsis
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Cardiac disorders
Sinus tachycardia
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Vascular disorders
Thromboembolic event
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Infections and infestations
Urinary tract infection
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
6.0%
3/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Investigations
Urine output decreased
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Reproductive system and breast disorders
Vaginal fistula
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Reproductive system and breast disorders
Vaginal pain
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
3/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
Other adverse events
| Measure |
Treatment (ADXS11-001)
n=50 participants at risk
Patients receive live-attenuated Listeria monocytogenes cancer vaccine ADXS11-001 IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
28.0%
14/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
8.0%
4/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Investigations
Alanine aminotransferase increased
|
22.0%
11/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Investigations
Alkaline phosphatase increased
|
24.0%
12/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Anal pain
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
26.0%
13/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Psychiatric disorders
Anxiety
|
14.0%
7/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
4/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Ascites
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Investigations
Aspartate aminotransferase increased
|
26.0%
13/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
34.0%
17/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Renal and urinary disorders
Bladder perforation
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Renal and urinary disorders
Bladder spasm
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Bloating
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Eye disorders
Blurred vision
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Investigations
Cardiac troponin I increased
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Cardiac disorders
Chest pain - cardiac
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
General disorders
Chills
|
58.0%
29/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Investigations
Cholesterol high
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Constipation
|
36.0%
18/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.0%
6/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Investigations
Creatinine increased
|
10.0%
5/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Renal and urinary disorders
Cystitis noninfective
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Immune system disorders
Cytokine release syndrome
|
16.0%
8/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Psychiatric disorders
Depression
|
16.0%
8/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Diarrhea
|
6.0%
3/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Nervous system disorders
Dizziness
|
14.0%
7/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Dysphagia
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
24.0%
12/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
General disorders
Edema limbs
|
26.0%
13/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
General disorders
Edema trunk
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Eye disorders
Eye disorders - Other, specify
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
General disorders
Fatigue
|
74.0%
37/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
General disorders
Fever
|
40.0%
20/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
General disorders
Flu like symptoms
|
16.0%
8/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Vascular disorders
Flushing
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Investigations
GGT increased
|
28.0%
14/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Hepatobiliary disorders
Gallbladder pain
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.0%
3/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
5/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Nervous system disorders
Headache
|
36.0%
18/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Renal and urinary disorders
Hematuria
|
8.0%
4/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Vascular disorders
Hot flashes
|
8.0%
4/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
10.0%
5/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
10/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Vascular disorders
Hypertension
|
8.0%
4/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
22.0%
11/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.0%
7/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.0%
7/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
10/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.0%
8/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.0%
4/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Vascular disorders
Hypotension
|
32.0%
16/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Investigations
INR increased
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
General disorders
Infusion related reaction
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Psychiatric disorders
Insomnia
|
16.0%
8/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
General disorders
Localized edema
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Vascular disorders
Lymphedema
|
6.0%
3/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Investigations
Lymphocyte count decreased
|
10.0%
5/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
General disorders
Malaise
|
8.0%
4/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Nervous system disorders
Memory impairment
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
24.0%
12/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.0%
3/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
20/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
General disorders
Non-cardiac chest pain
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
General disorders
Pain
|
18.0%
9/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
5/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Nervous system disorders
Paresthesia
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Reproductive system and breast disorders
Pelvic pain
|
10.0%
5/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Infections and infestations
Peripheral nerve infection
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.0%
7/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Eye disorders
Photophobia
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Infections and infestations
Rhinitis infective
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Cardiac disorders
Sinus tachycardia
|
22.0%
11/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Nervous system disorders
Somnolence
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.0%
3/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Vascular disorders
Thromboembolic event
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Renal and urinary disorders
Urinary frequency
|
10.0%
5/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Renal and urinary disorders
Urinary retention
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
5/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Renal and urinary disorders
Urinary tract pain
|
6.0%
3/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Renal and urinary disorders
Urinary urgency
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Reproductive system and breast disorders
Vaginal fistula
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
6.0%
3/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Infections and infestations
Vaginal infection
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Reproductive system and breast disorders
Vaginal pain
|
4.0%
2/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Cardiac disorders
Ventricular tachycardia
|
2.0%
1/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
15/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
|
Investigations
Weight loss
|
8.0%
4/50 • For each patient, adverse events are collected from study entry until the end of follow up, an average of 4 years 7 months.
|
Additional Information
Christopher Purdy on behalf of Austin Miller PhD
NRG Oncology
Phone: (716) 845-1300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60