Trial Outcomes & Findings for Lenvatinib (LEN) in Combination With Pembrolizumab (KEYtruda) in Subjects With Locally Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma (The LENKYN Trial) (NCT NCT04267120)

Last Updated: 2025-03-21

Results Overview

* ORR is defined as the proportion of subjects who have a best overall response of complete response (CR) or partial response (PR) * CR: Disappearance of target and non-target lesions and normalization of tumor markers. * PR: At least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non target lesions must be non-progressive disease.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Through completion of treatment (median length 287 days, full range 92-728 days)

Results posted on

2025-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	Lenvatinib + Pembrolizumab * Lenvatinib 20 mg/day will be administered orally on a daily basis and pembrolizumab 200 mg will be infused once every 3 weeks. * Subjects may be treated with pembrolizumab for a maximum of 35 cycles or approximately 2 years, but treatment with lenvatinib can continue beyond 2 years if the subject does not meet other treatment discontinuation criteria.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lenvatinib (LEN) in Combination With Pembrolizumab (KEYtruda) in Subjects With Locally Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma (The LENKYN Trial)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenvatinib + Pembrolizumab n=11 Participants * Lenvatinib 20 mg/day will be administered orally on a daily basis and pembrolizumab 200 mg will be infused once every 3 weeks. * Subjects may be treated with pembrolizumab for a maximum of 35 cycles or approximately 2 years, but treatment with lenvatinib can continue beyond 2 years if the subject does not meet other treatment discontinuation criteria.
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 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	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	9 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	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Through completion of treatment (median length 287 days, full range 92-728 days)

Population: One patient was not evaluable as they did not have a disease assessment outside of the baseline disease assessment.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=10 Participants * Lenvatinib 20 mg/day will be administered orally on a daily basis and pembrolizumab 200 mg will be infused once every 3 weeks. * Subjects may be treated with pembrolizumab for a maximum of 35 cycles or approximately 2 years, but treatment with lenvatinib can continue beyond 2 years if the subject does not meet other treatment discontinuation criteria.
Overall Response Rate (ORR)	4 Participants

SECONDARY outcome

Timeframe: From start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days)

-Will be graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=11 Participants * Lenvatinib 20 mg/day will be administered orally on a daily basis and pembrolizumab 200 mg will be infused once every 3 weeks. * Subjects may be treated with pembrolizumab for a maximum of 35 cycles or approximately 2 years, but treatment with lenvatinib can continue beyond 2 years if the subject does not meet other treatment discontinuation criteria.
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Nail discoloration	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Nausea	6 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Neutrophil count decreased	2 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Vision decreased	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Vitiligo	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Voice alteration	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Vomiting	3 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Abdominal pain	2 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Adrenal insufficiency	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Alanine aminotransferase increased	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Alopecia	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Anemia	3 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Anorexia	5 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Aspartate aminotransferase increased	3 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Cholesterol high	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Cognitive disturbance	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Constipation	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Creatinine increased	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Depression	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Diarrhea	6 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Dizziness	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Dry skin	2 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Dysgeusia	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Dysphagia	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Enterocolitis infectious	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Eosinophilia	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Erythematous rash	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Fatigue	6 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Fecal incontinence	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Generalized edema	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Headache	3 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Hemorrhoids	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Hernia surgery	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Hoarseness	2 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Hypertension	6 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Hyperthyroidism	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Ileus	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Incisional hernia	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Insomnia	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Intra-abdominal hemorrhage	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Itchy scalp	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Jejunal fistula	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Mucositis oral	2 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Myalgia	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Non-cardiac chest pain	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Pain - bottoms of feet	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Palmar-plantar erythrodysesthesia syndrome	5 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Papulopustular rash	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Peripheral sensory neuropathy	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Platelet count decreased	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Proteinuria	4 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Pruritus	2 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Pruritic Rash	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Rash	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Rash acneiform	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Rash maculo-papular	2 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Restless Leg Syndrome	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Scalp sores	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Sensitive Hands	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Sensitive skin/sores on face	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Skin Soreness	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Sore throat	2 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Stomach pain	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Thyroid stimulating hormone increased	8 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Warm hands and feet	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant White blood cell decreased	1 Participants
Safety and Tolerability of Regimen as Measured by Related Adverse Events Experienced by Participant Weight loss	2 Participants

SECONDARY outcome

Timeframe: At 3 months

* PFS is defined as the time from date of first dose of study drug to date of first documentation of disease progression or death, whichever occurs first. * Progressive disease: At least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) AND an absolute increase of ≥5 mm. Appearance of new lesions will also constitute PD (including lesions in previously unassessed areas). * Cumulative probability is on a scale of 0-1.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=11 Participants * Lenvatinib 20 mg/day will be administered orally on a daily basis and pembrolizumab 200 mg will be infused once every 3 weeks. * Subjects may be treated with pembrolizumab for a maximum of 35 cycles or approximately 2 years, but treatment with lenvatinib can continue beyond 2 years if the subject does not meet other treatment discontinuation criteria.
Cumulative Probability of Progression-free Survival (PFS)	1.0000 probability Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: At 6 months

* PFS is defined as the time from date of first dose of study drug t date of first documentation of disease progression or death, whichever occurs first. * Progressive disease: At least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) AND an absolute increase of ≥5 mm. Appearance of new lesions will also constitute PD (including lesions in previously unassessed areas). * Cumulative probability is on a scale of 0-1.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=11 Participants * Lenvatinib 20 mg/day will be administered orally on a daily basis and pembrolizumab 200 mg will be infused once every 3 weeks. * Subjects may be treated with pembrolizumab for a maximum of 35 cycles or approximately 2 years, but treatment with lenvatinib can continue beyond 2 years if the subject does not meet other treatment discontinuation criteria.
Cumulative Probability of Progression-free Survival (PFS)	0.9091 probability Interval 0.5081 to 0.9867

SECONDARY outcome

Timeframe: At 12 months

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=11 Participants * Lenvatinib 20 mg/day will be administered orally on a daily basis and pembrolizumab 200 mg will be infused once every 3 weeks. * Subjects may be treated with pembrolizumab for a maximum of 35 cycles or approximately 2 years, but treatment with lenvatinib can continue beyond 2 years if the subject does not meet other treatment discontinuation criteria.
Cumulative Probability of Progression-free Survival (PFS)	0.7273 probability Interval 0.3708 to 0.9028

SECONDARY outcome

Timeframe: Through completion of follow-up (median length 602 days, full range 92-1244 days)

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=11 Participants * Lenvatinib 20 mg/day will be administered orally on a daily basis and pembrolizumab 200 mg will be infused once every 3 weeks. * Subjects may be treated with pembrolizumab for a maximum of 35 cycles or approximately 2 years, but treatment with lenvatinib can continue beyond 2 years if the subject does not meet other treatment discontinuation criteria.
Median Progression-free Survival (PFS)	19.78 months Interval 8.71 to 22.47

SECONDARY outcome

Timeframe: Through completion of follow-up (median length 602 days, full range 92-1244 days)

-OS is defined as the time from the date of first dose of study drug until date of death from any cause.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=11 Participants * Lenvatinib 20 mg/day will be administered orally on a daily basis and pembrolizumab 200 mg will be infused once every 3 weeks. * Subjects may be treated with pembrolizumab for a maximum of 35 cycles or approximately 2 years, but treatment with lenvatinib can continue beyond 2 years if the subject does not meet other treatment discontinuation criteria.
Median Overall Survival (OS)	19.78 months Interval 11.43 to 36.53

SECONDARY outcome

Timeframe: At 6 months

* OS is defined as the time from the date of first dose of study drug until date of death from any cause. * Cumulative probability is on a scale of 0-1.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=11 Participants * Lenvatinib 20 mg/day will be administered orally on a daily basis and pembrolizumab 200 mg will be infused once every 3 weeks. * Subjects may be treated with pembrolizumab for a maximum of 35 cycles or approximately 2 years, but treatment with lenvatinib can continue beyond 2 years if the subject does not meet other treatment discontinuation criteria.
Cumulative Probability of Overall Survival (OS)	0.9091 probability Interval 0.5081 to 0.9867

SECONDARY outcome

Timeframe: At 12 months

* OS is defined as the time from the date of first dose of study drug until date of death from any cause. * Cumulative probability is on a scale of 0-1.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=11 Participants * Lenvatinib 20 mg/day will be administered orally on a daily basis and pembrolizumab 200 mg will be infused once every 3 weeks. * Subjects may be treated with pembrolizumab for a maximum of 35 cycles or approximately 2 years, but treatment with lenvatinib can continue beyond 2 years if the subject does not meet other treatment discontinuation criteria.
Cumulative Probability of Overall Survival (OS)	0.8182 probability Interval 0.4474 to 0.9512

SECONDARY outcome

Timeframe: At 18 months

* OS is defined as the time from the date of first dose of study drug until date of death from any cause. * Cumulative probability is on a scale of 0-1.

Outcome measures

Outcome measures
Measure	Lenvatinib + Pembrolizumab n=11 Participants * Lenvatinib 20 mg/day will be administered orally on a daily basis and pembrolizumab 200 mg will be infused once every 3 weeks. * Subjects may be treated with pembrolizumab for a maximum of 35 cycles or approximately 2 years, but treatment with lenvatinib can continue beyond 2 years if the subject does not meet other treatment discontinuation criteria.
Cumulative Probability of Overall Survival (OS)	0.6364 probability Interval 0.2969 to 0.8452

Adverse Events

Lenvatinib + Pembrolizumab

Serious events: 6 serious events

Other events: 11 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Lenvatinib + Pembrolizumab n=11 participants at risk * Lenvatinib 20 mg/day will be administered orally on a daily basis and pembrolizumab 200 mg will be infused once every 3 weeks. * Subjects may be treated with pembrolizumab for a maximum of 35 cycles or approximately 2 years, but treatment with lenvatinib can continue beyond 2 years if the subject does not meet other treatment discontinuation criteria.
Cardiac disorders Atrial fibrillation	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Cardiac disorders Cardiac troponin I increased	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Dysphagia	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Ileus	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Jejunal fistula	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Small intestinal obstruction	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
General disorders Non-cardiac chest pain	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Infections and infestations Enterocolitis infectious	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Infections and infestations Lung infection	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Infections and infestations Sepsis	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease progression	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) New prostate cancer	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).

Other adverse events

Other adverse events
Measure	Lenvatinib + Pembrolizumab n=11 participants at risk * Lenvatinib 20 mg/day will be administered orally on a daily basis and pembrolizumab 200 mg will be infused once every 3 weeks. * Subjects may be treated with pembrolizumab for a maximum of 35 cycles or approximately 2 years, but treatment with lenvatinib can continue beyond 2 years if the subject does not meet other treatment discontinuation criteria.
Blood and lymphatic system disorders Anemia	54.5% 6/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Blood and lymphatic system disorders Eosinophilia	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Cardiac disorders Chest pain - cardiac	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Ear and labyrinth disorders Hearing impaired	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Endocrine disorders Adrenal insuffciency	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Endocrine disorders Hyperthyroidism	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Endocrine disorders Hypothyroidism	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Eye disorders Blurred vision	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Eye disorders Vision decreased	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Abdominal pain	36.4% 4/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Constipation	45.5% 5/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Dental pain	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Diarrhea	81.8% 9/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Dyspepsia	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Dysphagia	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Fecal incontinence	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Hemorrhoidal hemorrhage	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Hemorrhoids	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Ileus	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Intra-abdominal hemorrhage	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Mucositis oral	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Nausea	63.6% 7/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Stomach pain	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Gastrointestinal disorders Vomiting	63.6% 7/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
General disorders Pain - bottom of feet	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
General disorders Chills	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
General disorders Edema limbs	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
General disorders Facial abrasions	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
General disorders Fatigue	81.8% 9/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
General disorders Generalized edema	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
General disorders Malaise	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
General disorders Sweating	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Infections and infestations COVID-19 infection	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Infections and infestations Lung infection	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Infections and infestations Papulopustular rash	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Infections and infestations Upper respiratory infection	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Investigations Activated partial thromboplastin time prolonged	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Investigations Alanine aminotransferase increased	36.4% 4/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Investigations Alkaline phosphatase increased	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Investigations Aspartate aminotransferase increased	45.5% 5/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Investigations Blood bicarbonate increased	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Investigations Blood lactate dehydrogenase increased	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Investigations Cholesterol high	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Investigations Creatinine increased	36.4% 4/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Investigations INR increased	27.3% 3/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Investigations Lymphocyte count decreased	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Investigations Neutrophil count decreased	27.3% 3/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Investigations Platelet count decreased	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Investigations Thyroid stimulating hormone increased	72.7% 8/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Investigations Weight loss	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Investigations White blood cell decreased	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Metabolism and nutrition disorders Anorexia	54.5% 6/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Metabolism and nutrition disorders Dehydration	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Metabolism and nutrition disorders Hypercalcemia	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Metabolism and nutrition disorders Hyperglycemia	27.3% 3/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Metabolism and nutrition disorders Hyperkalemia	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Metabolism and nutrition disorders Hyperphosphatemia	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Metabolism and nutrition disorders Hypoalbuminemia	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Metabolism and nutrition disorders Hypocalcemia	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Metabolism and nutrition disorders Hypoglycemia	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Metabolism and nutrition disorders Hypokalemia	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Metabolism and nutrition disorders Hyponatremia	54.5% 6/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Metabolism and nutrition disorders Hypophosphatemia	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Musculoskeletal and connective tissue disorders Arthralgia	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Musculoskeletal and connective tissue disorders Back pain	27.3% 3/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Musculoskeletal and connective tissue disorders Hip pain	27.3% 3/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Musculoskeletal and connective tissue disorders Myalgia	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Musculoskeletal and connective tissue disorders Neck pain	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Musculoskeletal and connective tissue disorders Pain in extremity	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Nervous system disorders Cognitive disturbance	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Nervous system disorders Dizziness	36.4% 4/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Nervous system disorders Dysgeusia	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Nervous system disorders Headache	54.5% 6/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Nervous system disorders Peripheral sensory neuropathy	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Nervous system disorders Restless leg syndrome	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Psychiatric disorders Anxiety	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Psychiatric disorders Depression	27.3% 3/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Psychiatric disorders Insomnia	36.4% 4/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Renal and urinary disorders Acute kidney injury	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Renal and urinary disorders Dysuria	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Renal and urinary disorders Hematuria	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Renal and urinary disorders Proteinuria	45.5% 5/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Reproductive system and breast disorders Amenorrhea	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Respiratory, thoracic and mediastinal disorders Cough	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Respiratory, thoracic and mediastinal disorders Dyspnea	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Respiratory, thoracic and mediastinal disorders Hoarseness	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Respiratory, thoracic and mediastinal disorders Postnasal drip	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Respiratory, thoracic and mediastinal disorders Sore throat	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Respiratory, thoracic and mediastinal disorders Voice alteration	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Alopecia	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Dry skin	18.2% 2/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Erythematous rash	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Face sores	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Itchy scalp	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Nail discoloration	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	45.5% 5/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Pruritic rash	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Pruritus	36.4% 4/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Rash	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Rash acneiform	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Rash maculo-papular	27.3% 3/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Scalp sores	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Sensitive hands	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Sensitive skin	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Skin soreness	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Sores above pubis area	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Warm hands and feet	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Skin and subcutaneous tissue disorders Vitiligo	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Surgical and medical procedures Hernia surgery	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Surgical and medical procedures Incisional hernia	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Vascular disorders Flushing	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Vascular disorders Hot flashes	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Vascular disorders Hypertension	54.5% 6/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).
Vascular disorders Hypotension	9.1% 1/11 • Adverse events were collected from start of treatment through 120 days after last day of study treatment (median length of follow-up 397 days, full range 92-848 days). All-cause mortality was collected from start of treatment through completion of follow-up (median length 602 days, full range 92-1244 days).

Additional Information

Joel Picus, M.D.

Washington University School of Medicine

Phone: 314-362-9115

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place