Trial Outcomes & Findings for Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer (NCT NCT03734692)

NCT ID: NCT03734692

Last Updated: 2025-07-20

Results Overview

The proportion of subjects with the best response of complete response (CR), or partial response (PR) per Response Evaluation Criteria for Solid Tumors (RECIST 1.1). Per RECIST 1.1 , CR is defined as all target lesions gone; PR is defined as a \> 30% decrease in size of lesion from baseline.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE1/PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: At 13 weeks
• Results posted on: 2025-07-20

Participant Flow

Participant milestones

Measure	Cisplatin + Rintatolimod + Pembrolizumab Intraperitoneal (IP) cisplatin 50mg/m\^2 solution with IP rintatolimod 200 mg solution and IV pembrolizumab 200 mg solution. Rintatolimod: 200 mg by IP administration over 1-2 hours Pembrolizumab: 200 mg will be administered as a 30 minute IV infusion Cisplatin: 50mg/m\^2 solution
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer

Baseline characteristics by cohort

Measure	Cisplatin + Rintatolimod + Pembrolizumab n=24 Participants Intraperitoneal (IP) cisplatin 50mg/m\^2 solution with IP rintatolimod 200 mg solution and IV pembrolizumab 200 mg solution. Rintatolimod: 200 mg by IP administration over 1-2 hours Pembrolizumab: 200 mg will be administered as a 30 minute IV infusion Cisplatin: 50mg/m\^2 solution
Age, Continuous	68.0 years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Disease.Site.Diagnosis Malignant neoplasm of fallopian tube	2 Participants n=5 Participants
Disease.Site.Diagnosis Malignant neoplasm of ovary	2 Participants n=5 Participants
Disease.Site.Diagnosis Ovary	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 13 weeks

Population: Treated patients who were evaluable for radiologic response.

The proportion of subjects with the best response of complete response (CR), or partial response (PR) per Response Evaluation Criteria for Solid Tumors (RECIST 1.1). Per RECIST 1.1 , CR is defined as all target lesions gone; PR is defined as a > 30% decrease in size of lesion from baseline.

Outcome measures

Measure	Cisplatin + Rintatolimod + Pembrolizumab n=24 Participants Intraperitoneal (IP) cisplatin 50mg/m\^2 solution with IP rintatolimod 200 mg solution and IV pembrolizumab 200 mg solution. Rintatolimod: 200 mg by IP administration over 1-2 hours Pembrolizumab: 200 mg will be administered as a 30 minute IV infusion Cisplatin: 50mg/m\^2 solution
Objective Response Rate (ORR)	50 percentage of patients Interval 31.0 to 69.0

SECONDARY outcome

Timeframe: At baseline (pre-treatment) and at 12 weeks (after the start of treatment)

Population: Treated patients monitored for DLTs.

Number of patients who experience Adverse Events per CTCAE v5.0 related to study treatment, including any death not clearly due to disease or extraneous causes, AE leading to a dose delay of greater than 14 days in initiation of cycle 2, a DLT occurring during Cycle 1 of treatment: Grade ≥ 3 renal toxicity, diarrhea, skin toxicity, injection site reactions, anaphylaxis, hematologic toxicities lasting more than 48 hours (including neutropenia), non-hematologic toxicities, neurological symptoms, thrombocytopenia and hemorrhage, liver function test increase; Grade ≥ 2 or greater bronchospasm, allergic reaction or generalized urticaria, autoimmune reaction, pneumonitis; Fever > 41°C, uncontrolled for over 4 hours in the absence of a medical cause Evaluation of liver toxicity per Hy's Law: Drug causes hepatocellular injury (higher incidence of 3-fold or greater elevations above the ULN of ALT or AST); Total Bilirubin>2xULN (without initial cholestasis (elevated serum alkaline phosphatase)

Outcome measures

Measure	Cisplatin + Rintatolimod + Pembrolizumab n=24 Participants Intraperitoneal (IP) cisplatin 50mg/m\^2 solution with IP rintatolimod 200 mg solution and IV pembrolizumab 200 mg solution. Rintatolimod: 200 mg by IP administration over 1-2 hours Pembrolizumab: 200 mg will be administered as a 30 minute IV infusion Cisplatin: 50mg/m\^2 solution
DLTs Related to Treatment	0 patients

SECONDARY outcome

Timeframe: up to 4 years

The length of time during and after study treatment that a patient does not experience worsening disease. Per RECIST 1.1 or dies from any cause. Progression is defined as a > 20% increase from smallest sum of longest (lesion) diameter recorded since treatment started (best response - target lesions) and/or, enlargement of non-target lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 4 years

The length of time during and after study treatment that a patient remains alive without worsening disease. Per RECIST 1.1, progression is defined as a > 20% increase from smallest sum of longest (lesion) diameter recorded since treatment started (best response - target lesions) and/or, enlargement of non-target lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline (pre-treatment) and at 8 weeks (after the start of treatment)

Within-patient changes in number of CD8+ cells present in tumor tissue and peritoneal fluid.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at baseline (pre-treatment) and at 12 weeks (after the start of treatment)

Within-patient changes in number of CD3+ cells present in tumor tissue and peritoneal fluid.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: at baseline (pre-treatment) and at 12 weeks (after the start of treatment)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: at baseline (pre-treatment) and at 12 weeks (after the start of treatment)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: at baseline (pre-treatment) and at 12 weeks (after the start of treatment)

Outcome measures

Outcome data not reported

Adverse Events

Cisplatin + Rintatolimod + Pembrolizumab

Serious events: 9 serious events

Other events: 24 other events

Deaths: 12 deaths

Serious adverse events

Measure	Cisplatin + Rintatolimod + Pembrolizumab n=24 participants at risk Intraperitoneal (IP) cisplatin 50mg/m\^2 solution with IP rintatolimod 200 mg solution and IV pembrolizumab 200 mg solution. Rintatolimod: 200 mg by IP administration over 1-2 hours Pembrolizumab: 200 mg will be administered as a 30 minute IV infusion Cisplatin: 50mg/m\^2 solution
Gastrointestinal disorders Vomiting	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Small intestinal perforation	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Small intestinal obstruction	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Obstruction gastric	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Nausea	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Abdominal pain	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
General disorders Fever	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
General disorders Fatigue	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Infections and infestations Sepsis	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Infections and infestations Device related infection	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Metabolism and nutrition disorders Hyponatremia	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Metabolism and nutrition disorders Hypokalemia	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Metabolism and nutrition disorders Hyperglycemia	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Metabolism and nutrition disorders Dehydration	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Skin and subcutaneous tissue disorders Erythema multiforme	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Social circumstances Failure to thrive	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Vascular disorders Hypotension	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.

Other adverse events

Measure	Cisplatin + Rintatolimod + Pembrolizumab n=24 participants at risk Intraperitoneal (IP) cisplatin 50mg/m\^2 solution with IP rintatolimod 200 mg solution and IV pembrolizumab 200 mg solution. Rintatolimod: 200 mg by IP administration over 1-2 hours Pembrolizumab: 200 mg will be administered as a 30 minute IV infusion Cisplatin: 50mg/m\^2 solution
Blood and lymphatic system disorders Febrile neutropenia	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Blood and lymphatic system disorders Anemia	79.2% 19/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Cardiac disorders Sinus tachycardia	25.0% 6/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Cardiac disorders Sinus bradycardia	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Cardiac disorders Palpitations	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Ear and labyrinth disorders Vertigo	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Ear and labyrinth disorders Tinnitus	12.5% 3/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Endocrine disorders Adrenal insufficiency	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Eye disorders Watering eyes	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Eye disorders Eye pain	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Eye disorders Blurred vision	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Vomiting	33.3% 8/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Small intestinal perforation	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Small intestinal obstruction	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Oral dysesthesia	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Obstruction gastric	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Nausea	83.3% 20/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Gastrointestinal pain	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Bloody stools	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Gastroesophageal reflux disease	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Dysphagia	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Dyspepsia	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Dry mouth	12.5% 3/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Diarrhea	50.0% 12/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Constipation	20.8% 5/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Bloating	50.0% 12/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Ascites	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Abdominal pain	66.7% 16/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Gastrointestinal disorders Abdominal distension	12.5% 3/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
General disorders Pain	25.0% 6/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
General disorders Infusion site extravasation	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
General disorders Flu like symptoms	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
General disorders Fever	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
General disorders Fatigue	100.0% 24/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
General disorders Edema limbs	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
General disorders Chills	16.7% 4/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Immune system disorders Allergic reaction	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Infections and infestations Vaginal infection	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Infections and infestations Urinary tract infection	16.7% 4/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Infections and infestations Upper respiratory infection	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Infections and infestations Skin infection	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Infections and infestations Sepsis	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Infections and infestations Device related infection	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Infections and infestations Bacteremia	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Infections and infestations Abdominal infection	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Injury, poisoning and procedural complications Infusion related reaction	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Injury, poisoning and procedural complications Fall	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Injury, poisoning and procedural complications Bruising	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Investigations White blood cell decreased	29.2% 7/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Investigations Weight loss	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Investigations Platelet count decreased	12.5% 3/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Investigations Neutrophil count decreased	41.7% 10/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Investigations Lymphocyte count decreased	33.3% 8/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Investigations increased BUN	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Investigations Creatinine increased	20.8% 5/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Investigations Blood lactate dehydrogenase increased	29.2% 7/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Investigations Aspartate aminotransferase increased	16.7% 4/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Investigations Alkaline phosphatase increased	12.5% 3/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Metabolism and nutrition disorders Hypophosphatemia	20.8% 5/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Metabolism and nutrition disorders Hyponatremia	54.2% 13/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Metabolism and nutrition disorders Hypomagnesemia	87.5% 21/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Metabolism and nutrition disorders Hypokalemia	20.8% 5/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Metabolism and nutrition disorders Hypoglycemia	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Metabolism and nutrition disorders Hypocalcemia	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Metabolism and nutrition disorders Hypoalbuminemia	12.5% 3/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Metabolism and nutrition disorders Hyperuricemia	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Metabolism and nutrition disorders Hyperglycemia	25.0% 6/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Metabolism and nutrition disorders Hypercalcemia	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Metabolism and nutrition disorders Dehydration	12.5% 3/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Metabolism and nutrition disorders Anorexia	45.8% 11/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Musculoskeletal and connective tissue disorders Myalgia	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	12.5% 3/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Musculoskeletal and connective tissue disorders Back pain	20.8% 5/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 3/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Nervous system disorders Tremor	16.7% 4/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Nervous system disorders Syncope	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Nervous system disorders Peripheral sensory neuropathy	12.5% 3/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Nervous system disorders Peripheral motor neuropathy	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Nervous system disorders Lethargy	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Nervous system disorders Headache	29.2% 7/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Nervous system disorders Dysgeusia	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Nervous system disorders Dizziness	12.5% 3/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Nervous system disorders Akathisia	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Psychiatric disorders Claustrophobic	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Psychiatric disorders Insomnia	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Psychiatric disorders Confusion	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Psychiatric disorders Anxiety	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Renal and urinary disorders Urinary incontinence	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Renal and urinary disorders Urinary frequency	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Renal and urinary disorders Proteinuria	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Renal and urinary disorders Hematuria	12.5% 3/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Renal and urinary disorders Chronic kidney disease	12.5% 3/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Reproductive system and breast disorders Pelvic pain	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Respiratory, thoracic and mediastinal disorders Postnasal drip	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Respiratory, thoracic and mediastinal disorders Nasal congestion	29.2% 7/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Respiratory, thoracic and mediastinal disorders Hiccups	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 3/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Skin and subcutaneous tissue disorders Skin redness/ irritation	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Skin and subcutaneous tissue disorders RUQ Redness/ Irritation	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Skin and subcutaneous tissue disorders Dermatologic Toxicity	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Skin and subcutaneous tissue disorders Cellulitus	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Skin and subcutaneous tissue disorders Rash maculo-papular	16.7% 4/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Skin and subcutaneous tissue disorders Rash acneiform	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Skin and subcutaneous tissue disorders Pruritus	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Skin and subcutaneous tissue disorders Hyperhidrosis	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Skin and subcutaneous tissue disorders Erythema multiforme	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Skin and subcutaneous tissue disorders Bullous dermatitis	8.3% 2/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Skin and subcutaneous tissue disorders Alopecia	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Social circumstances Failure to thrive	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Vascular disorders Thromboembolic event	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Vascular disorders Hypotension	20.8% 5/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Vascular disorders Hypertension	62.5% 15/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.
Vascular disorders Hematoma	4.2% 1/24 • Adverse Events data collected for 5 years, 1 month All-Cause Mortality data provided to date; data still being collected.

Additional Information

Barbara Stadterman, MPH, CCRP

UPMC Hillman Cancer Center

Phone: 4126475554

Email: stadtermanbm@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place