Trial Outcomes & Findings for Interleukin-2 and Pembrolizumab for Metastatic Kidney Cancer (NCT NCT02964078)
NCT ID: NCT02964078
Last Updated: 2026-04-02
Results Overview
Overall Response According to Immune-related response criteria (irRC). Overall response rate ORR is defined with confirmation of the response status Complete Response (CR) or Partial Response (PR) among the combination treatment population patients; the binomial estimate and its one-sided 95% confidence interval will be reported. CR: Disappearance of all lesions in two consecutive observation not less than 4 weeks apart. PR: ≥50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart.
COMPLETED
PHASE2
27 participants
Up to 24 months
2026-04-02
Participant Flow
Participant milestones
| Measure |
Pembrolizumab and Interleukin-2
Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interleukin-2 and Pembrolizumab for Metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
Pembrolizumab and Interleukin-2
n=27 Participants
Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsOverall Response According to Immune-related response criteria (irRC). Overall response rate ORR is defined with confirmation of the response status Complete Response (CR) or Partial Response (PR) among the combination treatment population patients; the binomial estimate and its one-sided 95% confidence interval will be reported. CR: Disappearance of all lesions in two consecutive observation not less than 4 weeks apart. PR: ≥50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart.
Outcome measures
| Measure |
Pembrolizumab and Interleukin-2
n=27 Participants
Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
|
|---|---|
|
Overall Response Rate (ORR)
|
70.4 percentage of participants
Interval 54.6 to 100.0
|
SECONDARY outcome
Timeframe: Up to 24 monthsAnalysis: Overall Survival (OS) of ITT patients using Kaplan-Meier estimate, counting from the eligible date to death from any cause, or censored on end of known follow up, either within this study or in the Prometheus Laboratories sponsored PROCLAIM registry (PROCLAIM Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy, NCT01415167).
Outcome measures
| Measure |
Pembrolizumab and Interleukin-2
n=27 Participants
Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
|
|---|---|
|
Overall Survival (OS) of Intent to Treat (ITT) Population
|
1 proportion of participants
Interval 0.871 to 1.0
|
SECONDARY outcome
Timeframe: Up to 24 monthsProgression-free survival (PFS) of ITT patients using Kaplan Meier estimate, from the confirmed eligible date to the first occurrence of disease progression or death, from any cause, or lost to follow up, whichever is earliest; or censored at last follow-up during study. Progressive Disease (PD): At least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 weeks apart.
Outcome measures
| Measure |
Pembrolizumab and Interleukin-2
n=27 Participants
Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
|
|---|---|
|
Progression Free Survival (PFS)
|
.630 proportion of participants
Interval 0.421 to 0.781
|
Adverse Events
Pembrolizumab and Interleukin-2
Serious adverse events
| Measure |
Pembrolizumab and Interleukin-2
n=27 participants at risk
Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
|
|---|---|
|
Cardiac disorders
Atrial fibrilation
|
11.1%
3/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Cardiac disorders
Atrial flutter
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Cardiac disorders
Supraventricular tachycardia
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Cardiac disorders
Ventricular tachycardia
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
General disorders
Flu like symptoms
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
General disorders
Infusion related reaction
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Investigations
Creatinine increased
|
11.1%
3/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.8%
4/27 • Number of events 8 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
11.1%
3/27 • Number of events 4 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Nervous system disorders
Edema cerebral
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Nervous system disorders
Headache
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Nervous system disorders
Intracranial hemorrhage
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Nervous system disorders
Nervous system disorders - Other
|
7.4%
2/27 • Number of events 4 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
22.2%
6/27 • Number of events 6 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
29.6%
8/27 • Number of events 8 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
3/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Vascular disorders
Capillary leak syndrome
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Vascular disorders
Hypotension
|
25.9%
7/27 • Number of events 12 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Investigations
Blood bilirubin increased
|
11.1%
3/27 • Number of events 4 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Investigations
Alanine aminotransferase increased
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
3.7%
1/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Investigations
Lymphocyte count decreased
|
25.9%
7/27 • Number of events 19 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
29.6%
8/27 • Number of events 14 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Vascular disorders
Hypertension
|
11.1%
3/27 • Number of events 6 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Vascular disorders
Vascular disorders - Other
|
7.4%
2/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Blood and lymphatic system disorders
Leukocytosis
|
18.5%
5/27 • Number of events 10 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
General disorders
Fatigue
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.4%
2/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
3/27 • Number of events 4 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
General disorders
Pain
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.7%
1/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Nervous system disorders
Nystagmus
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
Other adverse events
| Measure |
Pembrolizumab and Interleukin-2
n=27 participants at risk
Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
|
|---|---|
|
Investigations
Creatinine increased
|
25.9%
7/27 • Number of events 12 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Investigations
Lymphocyte count decreased
|
25.9%
7/27 • Number of events 19 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Investigations
Blood bilirubin increased
|
18.5%
5/27 • Number of events 6 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Investigations
Urine output decreased
|
11.1%
3/27 • Number of events 4 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Investigations
Alanine aminotransferase increased
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Investigations
Investigations - Other
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Investigations
Weight gain
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
29.6%
8/27 • Number of events 14 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.5%
5/27 • Number of events 9 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.4%
2/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.7%
1/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Hyperalbuminemia
|
3.7%
1/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Metabolism and nutrition disorders
Obesity
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Cardiac disorders
Sinus tachycardia
|
29.6%
8/27 • Number of events 10 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Cardiac disorders
Atrial fibrillation
|
14.8%
4/27 • Number of events 5 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Cardiac disorders
Chest pain - cardiac
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Cardiac disorders
Ventricular tachycardia
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Cardiac disorders
Asystole
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Cardiac disorders
Atrial flutter
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Cardiac disorders
Cardiac disorders - Other
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Cardiac disorders
Sinus bradycardia
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Vascular disorders
Hypotension
|
14.8%
4/27 • Number of events 6 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Vascular disorders
Hypertension
|
14.8%
4/27 • Number of events 8 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Vascular disorders
Capillary leak syndrome
|
11.1%
3/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Vascular disorders
Vascular disorders - Other
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
22.2%
6/27 • Number of events 7 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
22.2%
6/27 • Number of events 6 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
22.2%
6/27 • Number of events 9 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
3/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
3/27 • Number of events 4 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders -Other
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
General disorders
Fatigue
|
11.1%
3/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
General disorders
Fever
|
11.1%
3/27 • Number of events 4 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
General disorders
Edema limbs
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
General disorders
Pain
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
General disorders
Chills
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
General disorders
Flu like symptoms
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
General disorders
General disorders and administration site conditions -Other
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
7.4%
2/27 • Number of events 3 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Gastrointestinal disorders
Nausea
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
1/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Gastrointestinal disorders
Constipation
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Gastrointestinal disorders
Dysphagia
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Blood and lymphatic system disorders
Leukocytosis
|
22.2%
6/27 • Number of events 10 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
3.7%
1/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.2%
6/27 • Number of events 6 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Nervous system disorders
Headache
|
14.8%
4/27 • Number of events 5 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Nervous system disorders
Intracranial hemorrhage
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Nervous system disorders
Dizziness
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Nervous system disorders
Facial muscle weakness
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Nervous system disorders
Lethargy
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Nervous system disorders
Nervous system disorders - Other
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Nervous system disorders
Nystagmus
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Nervous system disorders
Tremor
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.8%
4/27 • Number of events 7 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Infections and infestations
Infections and Infestations - Other
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Infections and infestations
Upper respiratory infection
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
7.4%
2/27 • Number of events 2 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Endocrine disorders
Hyperthyroidism
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Eye disorders
Blurred vision
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
|
Reproductive system and breast disorders
Dyspareunia
|
3.7%
1/27 • Number of events 1 • Adverse events recorded from Cycle 1 day 1 through 30 days after cessation of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place