Trial Outcomes & Findings for Study of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Metastatic Pancreatic Cancer (NCT NCT05014776)

Last Updated: 2026-04-28

Results Overview

Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will not included in the analysis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

9 months

Results posted on

2026-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 Tadalafil: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Tadalafil (20 mg) will be administered orally every day on days 3-21 for cycles 1-6. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on Day 1 of cycles 1-6. Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (50mg) will be administered IV on Day 1 of Cycles 1, 3, and 5. CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 \[1 × 10\^9 colony forming units (CFU) in 100ml NS\] will be administered IV on Day 2 of Cycles 1-6.
Overall Study STARTED	17
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Metastatic Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 n=17 Participants Tadalafil: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Tadalafil (20 mg) will be administered orally every day on days 3-21 for cycles 1-6. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on Day 1 of cycles 1-6. Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (50mg) will be administered IV on Day 1 of Cycles 1, 3, and 5. CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 \[1 × 10\^9 colony forming units (CFU) in 100ml NS\] will be administered IV on Day 2 of Cycles 1-6.
Age, Categorical <=18 years	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=9 Participants
Age, Categorical >=65 years	10 Participants n=9 Participants
Sex: Female, Male Female	8 Participants n=9 Participants
Sex: Female, Male Male	9 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	2 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	5 Participants n=9 Participants
Race (NIH/OMB) White	9 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=9 Participants
Region of Enrollment United States	17 Participants n=9 Participants

PRIMARY outcome

Timeframe: 9 months

Outcome measures

Outcome measures
Measure	Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 n=17 Participants Tadalafil: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Tadalafil (20 mg) will be administered orally every day on days 3-21 for cycles 1-6. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on Day 1 of cycles 1-6. Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (50mg) will be administered IV on Day 1 of Cycles 1, 3, and 5. CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 \[1 × 10\^9 colony forming units (CFU) in 100ml NS\] will be administered IV on Day 2 of Cycles 1-6.
Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)	0 Participants

SECONDARY outcome

Timeframe: 9 months

Outcome measures

Outcome measures
Measure	Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 n=17 Participants Tadalafil: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Tadalafil (20 mg) will be administered orally every day on days 3-21 for cycles 1-6. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on Day 1 of cycles 1-6. Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (50mg) will be administered IV on Day 1 of Cycles 1, 3, and 5. CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 \[1 × 10\^9 colony forming units (CFU) in 100ml NS\] will be administered IV on Day 2 of Cycles 1-6.
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation	0 Participants

Adverse Events

Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207

Serious events: 12 serious events

Other events: 17 other events

Deaths: 16 deaths

Serious adverse events

Serious adverse events
Measure	Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 n=17 participants at risk Tadalafil: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Tadalafil (20 mg) will be administered orally every day on days 3-21 for cycles 1-6. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on Day 1 of cycles 1-6. Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (50mg) will be administered IV on Day 1 of Cycles 1, 3, and 5. CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 \[1 × 10\^9 colony forming units (CFU) in 100ml NS\] will be administered IV on Day 2 of Cycles 1-6.
Hepatobiliary disorders Cholangitis	5.9% 1/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
General disorders Disease Progression	64.7% 11/17 • Number of events 11 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Abdominal pain	17.6% 3/17 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Blood and lymphatic system disorders Anemia	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Biliary Obstruction	11.8% 2/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Bowel Obstruction	11.8% 2/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Hepatobiliary disorders Hepatic failure	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Infections and infestations Lung infection	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Infections and infestations Sepsis	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Nervous system disorders Stroke	11.8% 2/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.

Other adverse events

Other adverse events
Measure	Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 n=17 participants at risk Tadalafil: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Tadalafil (20 mg) will be administered orally every day on days 3-21 for cycles 1-6. Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on Day 1 of cycles 1-6. Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (50mg) will be administered IV on Day 1 of Cycles 1, 3, and 5. CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 \[1 × 10\^9 colony forming units (CFU) in 100ml NS\] will be administered IV on Day 2 of Cycles 1-6.
Gastrointestinal disorders Anorexia	17.6% 3/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Psychiatric disorders Anxiety	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Abdominal pain	29.4% 5/17 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Investigations Alanine aminotransferase increased	23.5% 4/17 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Investigations Alkaline phosphatase increased	11.8% 2/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	23.5% 4/17 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Blood and lymphatic system disorders Anemia	11.8% 2/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Musculoskeletal and connective tissue disorders Arthralgia	23.5% 4/17 • Number of events 10 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Ascites	17.6% 3/17 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Investigations Aspartate aminotransferase increased	17.6% 3/17 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Musculoskeletal and connective tissue disorders Back pain	11.8% 2/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Bloating	17.6% 3/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Musculoskeletal and connective tissue disorders Bone pain	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Skin and subcutaneous tissue disorders Bruising	5.9% 1/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
General disorders Chills	100.0% 17/17 • Number of events 39 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Cough	29.4% 5/17 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Investigations Creatinine increased	23.5% 4/17 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Dark stool	5.9% 1/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Psychiatric disorders Depression	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Diarrhea	29.4% 5/17 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Nervous system disorders Dizziness	11.8% 2/17 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Dry mouth	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Skin and subcutaneous tissue disorders Dry skin	11.8% 2/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Nervous system disorders Dysphasia	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.8% 2/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
General disorders Edema	41.2% 7/17 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Injury, poisoning and procedural complications Fall	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
General disorders Fatigue	41.2% 7/17 • Number of events 8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
General disorders Fever	94.1% 16/17 • Number of events 41 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Musculoskeletal and connective tissue disorders Flank pain	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Flatulence	5.9% 1/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Eye disorders Floaters	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Musculoskeletal and connective tissue disorders Fracture	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Nervous system disorders Headache	41.2% 7/17 • Number of events 9 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Hoarseness	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	11.8% 2/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Vascular disorders Hypertension	76.5% 13/17 • Number of events 27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Endocrine disorders Hyperthyroidism	17.6% 3/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Vascular disorders Hypotension	29.4% 5/17 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Endocrine disorders Hypothyroidism	17.6% 3/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Infections and infestations COVID Infection	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Injury, poisoning and procedural complications Infusion related reaction	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Psychiatric disorders Insomnia	17.6% 3/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Nervous system disorders Lethargy	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Blood and lymphatic system disorders Lymphocyte count decreased	58.8% 10/17 • Number of events 23 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Musculoskeletal and connective tissue disorders Myalgia	35.3% 6/17 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	17.6% 3/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Nausea	23.5% 4/17 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
General disorders Non-cardiac chest pain	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
General disorders Pain	47.1% 8/17 • Number of events 10 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Musculoskeletal and connective tissue disorders Pain in extremity	17.6% 3/17 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Eye disorders Photophobia	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Blood and lymphatic system disorders Platelet count decreased	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Pleural hemorrhage	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Postnasal drip	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Skin and subcutaneous tissue disorders Pruritus	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Infections and infestations Shingles	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Cardiac disorders Sinus tachycardia	70.6% 12/17 • Number of events 21 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Lump	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Skin and subcutaneous tissue disorders Skin ulceration	5.9% 1/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Nervous system disorders Somnolence	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Sore throat	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Injury, poisoning and procedural complications Spinal fracture	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Investigations Thyroid stimulating hormone increased	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Ear and labyrinth disorders Tinnitus	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Reproductive system and breast disorders Vaginal discharge	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Vomiting	23.5% 4/17 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Investigations Weight gain	23.5% 4/17 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Investigations Weight loss	47.1% 8/17 • Number of events 9 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Abdominal distension	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Gastrointestinal disorders Gastroesophageal reflux disease	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Metabolism and nutrition disorders Hyperkalemia	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Metabolism and nutrition disorders Hyponatremia	5.9% 1/17 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.9% 1/17 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.
Cardiac disorders Sinus bradycardia	23.5% 4/17 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 12 months. All-cause mortality was evaluated for up to 16 months.

Additional Information

Katherine Bever, MD

SKCCC Johns Hopkins Medical Institution

Phone: 443-287-0966

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place