Trial Outcomes & Findings for Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer (NCT NCT03367871)

Last Updated: 2024-06-18

Results Overview

Objective response defined as the percentage of patients showing complete or partial response to study therapy. Response to therapy will be evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

Up to 24 months

Results posted on

2024-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	Pembrolizumab, Chemotherapy, Bevacizumab On day 1 of each 21 day cycle, participants will be administered Pembrolizumab 200mg (IV); Chemotherapy including Paclitaxel 175mg/m2 or 135 mg/m2 (IV), and Cisplatin 50mg/m2 (IV) or Carboplatin area under the curve (AUC) 5; and Bevacizumab 15mg/kg (IV). Pembrolizumab: IV Paclitaxel: Administered intravenously (IV) on day 1 Cisplatin: Administered intravenously (IV) on day 1 Carboplatin: Administered intravenously (IV) on day 1 Bevacizumab: Administered intravenously (IV) on day 1
Overall Study STARTED	17
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab, Chemotherapy, Bevacizumab On day 1 of each 21 day cycle, participants will be administered Pembrolizumab 200mg (IV); Chemotherapy including Paclitaxel 175mg/m2 or 135 mg/m2 (IV), and Cisplatin 50mg/m2 (IV) or Carboplatin area under the curve (AUC) 5; and Bevacizumab 15mg/kg (IV). Pembrolizumab: IV Paclitaxel: Administered intravenously (IV) on day 1 Cisplatin: Administered intravenously (IV) on day 1 Carboplatin: Administered intravenously (IV) on day 1 Bevacizumab: Administered intravenously (IV) on day 1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab, Chemotherapy, Bevacizumab n=17 Participants On day 1 of each 21 day cycle, participants will be administered Pembrolizumab 200mg (IV); Chemotherapy including Paclitaxel 175mg/m2 or 135 mg/m2 (IV), and Cisplatin 50mg/m2 (IV) or Carboplatin area under the curve (AUC) 5; and Bevacizumab 15mg/kg (IV). Pembrolizumab: IV Paclitaxel: Administered intravenously (IV) on day 1 Cisplatin: Administered intravenously (IV) on day 1 Carboplatin: Administered intravenously (IV) on day 1 Bevacizumab: Administered intravenously (IV) on day 1
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=93 Participants
Age, Categorical >=65 years	3 Participants n=93 Participants
Sex: Female, Male Female	17 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	8 Participants n=93 Participants
Race (NIH/OMB) White	9 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Population: Participants who completed at least one cycle of study therapy.

Outcome measures

Outcome measures
Measure	Pembrolizumab, Chemotherapy, Bevacizumab n=16 Participants On day 1 of each 21 day cycle, participants will be administered Pembrolizumab 200mg (IV); Chemotherapy including Paclitaxel 175mg/m2 or 135 mg/m2 (IV), and Cisplatin 50mg/m2 (IV) or Carboplatin area under the curve (AUC) 5; and Bevacizumab 15mg/kg (IV). Pembrolizumab: IV Paclitaxel: Administered intravenously (IV) on day 1 Cisplatin: Administered intravenously (IV) on day 1 Carboplatin: Administered intravenously (IV) on day 1 Bevacizumab: Administered intravenously (IV) on day 1
Objective Response (OR)	75 percentage of participants Interval 53.8 to 96.2

SECONDARY outcome

Timeframe: Up to 24 months

Population: Participants who received at least one dose of study therapy.

PFS is defined as percentage of participants without disease progression at time of study discontinuation will be assessed.

Outcome measures

Outcome measures
Measure	Pembrolizumab, Chemotherapy, Bevacizumab n=17 Participants On day 1 of each 21 day cycle, participants will be administered Pembrolizumab 200mg (IV); Chemotherapy including Paclitaxel 175mg/m2 or 135 mg/m2 (IV), and Cisplatin 50mg/m2 (IV) or Carboplatin area under the curve (AUC) 5; and Bevacizumab 15mg/kg (IV). Pembrolizumab: IV Paclitaxel: Administered intravenously (IV) on day 1 Cisplatin: Administered intravenously (IV) on day 1 Carboplatin: Administered intravenously (IV) on day 1 Bevacizumab: Administered intravenously (IV) on day 1
Progression-Free Survival (PFS)	48.7 percentage of participants Interval 22.8 to 70.4

SECONDARY outcome

Timeframe: Up to 24 months

Population: Participants who received at least one dose of study therapy.

The rate of Overall Survival (OS) in study participants at 24 months will be reported. OS is defined as the time from the date of start of treatment until date of death due to any cause or date of last known to be alive. The estimate of OS rate at the 24 months is calculated by the Kaplan-Meier method, which takes into account the censored event-free times.

Outcome measures

Outcome measures
Measure	Pembrolizumab, Chemotherapy, Bevacizumab n=17 Participants On day 1 of each 21 day cycle, participants will be administered Pembrolizumab 200mg (IV); Chemotherapy including Paclitaxel 175mg/m2 or 135 mg/m2 (IV), and Cisplatin 50mg/m2 (IV) or Carboplatin area under the curve (AUC) 5; and Bevacizumab 15mg/kg (IV). Pembrolizumab: IV Paclitaxel: Administered intravenously (IV) on day 1 Cisplatin: Administered intravenously (IV) on day 1 Carboplatin: Administered intravenously (IV) on day 1 Bevacizumab: Administered intravenously (IV) on day 1
Overall Survival (OS)	58.3 percentage of participants Interval 29.9 to 79.1

SECONDARY outcome

Timeframe: Up to 15 months

Population: Participants who received at least one dose of study therapy.

The number of study participants experiencing treatment-related toxicity, including adverse events (AEs) and serious adverse events (SAEs), will be assessed. Treatment-related AEs and SAEs will be evaluated with respect to grade and relationship to treatment, using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03.

Outcome measures

Outcome measures
Measure	Pembrolizumab, Chemotherapy, Bevacizumab n=17 Participants On day 1 of each 21 day cycle, participants will be administered Pembrolizumab 200mg (IV); Chemotherapy including Paclitaxel 175mg/m2 or 135 mg/m2 (IV), and Cisplatin 50mg/m2 (IV) or Carboplatin area under the curve (AUC) 5; and Bevacizumab 15mg/kg (IV). Pembrolizumab: IV Paclitaxel: Administered intravenously (IV) on day 1 Cisplatin: Administered intravenously (IV) on day 1 Carboplatin: Administered intravenously (IV) on day 1 Bevacizumab: Administered intravenously (IV) on day 1
Number of Participants Experiencing Treatment-Related Toxicity Treatment-related Serious Adverse Events (SAEs)	2 Participants
Number of Participants Experiencing Treatment-Related Toxicity Treatment-related Adverse Events (AEs)	14 Participants

Adverse Events

Pembrolizumab, Chemotherapy, Bevacizumab

Serious events: 6 serious events

Other events: 17 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab, Chemotherapy, Bevacizumab n=17 participants at risk On day 1 of each 21 day cycle, participants will be administered Pembrolizumab 200mg (IV); Chemotherapy including Paclitaxel 175mg/m2 or 135 mg/m2 (IV), and Cisplatin 50mg/m2 (IV) or Carboplatin AUC 5; and Bevacizumab 15mg/kg (IV). Pembrolizumab: IV Paclitaxel: Administered intravenously (IV) on day 1 Cisplatin: Administered intravenously (IV) on day 1 Carboplatin: Administered intravenously (IV) on day 1 Bevacizumab: Administered intravenously (IV) on day 1
Blood and lymphatic system disorders Anemia	11.8% 2/17 • Number of events 3 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Gastrointestinal disorders Rectal Fistula	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Gastrointestinal disorders Anal Fistula	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
General disorders Fever	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Infections and infestations Infections and infestations - Other, specify	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Infections and infestations Urinary Tract Infection	11.8% 2/17 • Number of events 2 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Investigations Platelet count decreased	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Metabolism and nutrition disorders Hypokalemia	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Renal and urinary disorders Acute kidney injury	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Vascular disorders Thromboembolic event	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.

Other adverse events

Other adverse events
Measure	Pembrolizumab, Chemotherapy, Bevacizumab n=17 participants at risk On day 1 of each 21 day cycle, participants will be administered Pembrolizumab 200mg (IV); Chemotherapy including Paclitaxel 175mg/m2 or 135 mg/m2 (IV), and Cisplatin 50mg/m2 (IV) or Carboplatin AUC 5; and Bevacizumab 15mg/kg (IV). Pembrolizumab: IV Paclitaxel: Administered intravenously (IV) on day 1 Cisplatin: Administered intravenously (IV) on day 1 Carboplatin: Administered intravenously (IV) on day 1 Bevacizumab: Administered intravenously (IV) on day 1
Blood and lymphatic system disorders Anemia	47.1% 8/17 • Number of events 11 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Cardiac disorders Myocarditis	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Cardiac disorders Cardiac arrest	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Ear and labyrinth disorders Tinnitus	5.9% 1/17 • Number of events 2 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Endocrine disorders Hyperthyroidism	11.8% 2/17 • Number of events 2 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Endocrine disorders Hypothyroidism	11.8% 2/17 • Number of events 2 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Eye disorders Blurred vision	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Eye disorders Dry eye	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Eye disorders Eye disorders - Other, specify	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Eye disorders Watering eyes	5.9% 1/17 • Number of events 2 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Gastrointestinal disorders Abdominal distension	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Gastrointestinal disorders Abdominal pain	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Gastrointestinal disorders Anal hemorrhage	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Gastrointestinal disorders Ascites	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Gastrointestinal disorders Constipation	29.4% 5/17 • Number of events 5 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Gastrointestinal disorders Diarrhea	23.5% 4/17 • Number of events 12 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Gastrointestinal disorders Dry mouth	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Gastrointestinal disorders Enterocolitis	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Gastrointestinal disorders Gastroesophageal reflux disease	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Gastrointestinal disorders Mucositis oral	17.6% 3/17 • Number of events 3 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Gastrointestinal disorders Nausea	23.5% 4/17 • Number of events 4 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Gastrointestinal disorders Rectal pain	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Gastrointestinal disorders Vomiting	11.8% 2/17 • Number of events 7 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
General disorders Chills	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
General disorders Edema face	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
General disorders Edema limbs	5.9% 1/17 • Number of events 3 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
General disorders Fatigue	64.7% 11/17 • Number of events 15 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
General disorders Fever	17.6% 3/17 • Number of events 3 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
General disorders Infusion related reaction	5.9% 1/17 • Number of events 2 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
General disorders Localized edema	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
General disorders Pain	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Infections and infestations Papulopustular rash	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Infections and infestations Upper respiratory infection	11.8% 2/17 • Number of events 2 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Infections and infestations Urinary tract infection	23.5% 4/17 • Number of events 5 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Infections and infestations Vaginal infection	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Infections and infestations Vulval infection	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Injury, poisoning and procedural complications Bruising	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Investigations Alanine aminotransferase increased	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Investigations Creatinine increased	11.8% 2/17 • Number of events 2 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Investigations Neutrophil count decreased	47.1% 8/17 • Number of events 12 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Investigations Platelet count decreased	11.8% 2/17 • Number of events 3 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Metabolism and nutrition disorders Anorexia	11.8% 2/17 • Number of events 3 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Metabolism and nutrition disorders Hyponatremia	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Musculoskeletal and connective tissue disorders Back pain	11.8% 2/17 • Number of events 2 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Musculoskeletal and connective tissue disorders Bone pain	11.8% 2/17 • Number of events 2 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Musculoskeletal and connective tissue disorders Myalgia	17.6% 3/17 • Number of events 3 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Musculoskeletal and connective tissue disorders Neck pain	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Nervous system disorders Dysgeusia	11.8% 2/17 • Number of events 2 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Nervous system disorders Headache	17.6% 3/17 • Number of events 4 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Nervous system disorders Intracranial hemorrhage	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Nervous system disorders Peripheral motor neuropathy	11.8% 2/17 • Number of events 2 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Nervous system disorders Peripheral sensory neuropathy	64.7% 11/17 • Number of events 14 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Psychiatric disorders Restlessness	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Renal and urinary disorders Bladder spasm	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Renal and urinary disorders Cystitis noninfective	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Renal and urinary disorders Hematuria	11.8% 2/17 • Number of events 3 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Renal and urinary disorders Proteinuria	11.8% 2/17 • Number of events 2 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Renal and urinary disorders Urinary tract pain	5.9% 1/17 • Number of events 2 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Renal and urinary disorders Urinary urgency	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Reproductive system and breast disorders Pelvic pain	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Reproductive system and breast disorders Vaginal fistula	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Reproductive system and breast disorders Vaginal hemorrhage	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Respiratory, thoracic and mediastinal disorders Cough	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.8% 2/17 • Number of events 3 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Respiratory, thoracic and mediastinal disorders Epistaxis	17.6% 3/17 • Number of events 4 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Respiratory, thoracic and mediastinal disorders Hoarseness	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Respiratory, thoracic and mediastinal disorders Sore throat	5.9% 1/17 • Number of events 2 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Skin and subcutaneous tissue disorders Alopecia	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Skin and subcutaneous tissue disorders Dry skin	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Skin and subcutaneous tissue disorders Nail discoloration	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Skin and subcutaneous tissue disorders Pain of skin	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Skin and subcutaneous tissue disorders Photosensitivity	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Skin and subcutaneous tissue disorders Pruritus	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Skin and subcutaneous tissue disorders Rash acneiform	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Skin and subcutaneous tissue disorders Rash maculo-papular	23.5% 4/17 • Number of events 4 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	5.9% 1/17 • Number of events 1 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	17.6% 3/17 • Number of events 3 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Vascular disorders Hot flashes	11.8% 2/17 • Number of events 2 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.
Vascular disorders Hypertension	41.2% 7/17 • Number of events 13 • Up to 33 months. There were a total of seven deaths: Six patients died on study, one patient died off study.

Additional Information

Abdulrahman Sinno MD

University of Miami

Phone: +1 (305) 243-2233

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place