Trial Outcomes & Findings for Pembrolizumab (Keytruda) in Advanced Hepatocellular Carcinoma (NCT NCT02658019)

Last Updated: 2020-11-12

Results Overview

Disease control rate (DCR) will be calculated per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, as the percentage of patients with best overall response to protocol therapy of either complete response (CR), partial response (PR) or stable disease (SD) that is maintained for at least 8 weeks. Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1)for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

8 weeks

Results posted on

2020-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	Pembrolizumab in Advanced HCC Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.
Overall Study STARTED	29
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab in Advanced HCC Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.
Overall Study Adverse Event	1

Baseline Characteristics

Pembrolizumab (Keytruda) in Advanced Hepatocellular Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab in Advanced HCC n=29 Participants Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome measures
Measure	Pembrolizumab in Advanced HCC n=28 Participants Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.
Disease Control Rate (DCR) in Study Participants	46 percentage of participants Interval 27.5 to 66.1

PRIMARY outcome

Timeframe: Up to 2 years

Population: One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.

The safety of Pembrolizumab in HCC patients as measured by the incidence of treatment-related adverse events, including serious adverse events (SAEs), in study participants using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, per physician discretion. The number of participants experiencing toxicity attributed by treating physician as definitely, probably and possibly-related to study treatment will be reported.

Outcome measures

Outcome measures
Measure	Pembrolizumab in Advanced HCC n=29 Participants Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.
Number of Participants With Treatment-Related Adverse Events SAEs with Attribution of Definite Relation	0 Participants
Number of Participants With Treatment-Related Adverse Events SAEs with Attribution of Possible relation	6 Participants
Number of Participants With Treatment-Related Adverse Events SAEs with Attribution of Probable Relation	2 Participants
Number of Participants With Treatment-Related Adverse Events AEs with Attribution of Definite Relation	0 Participants
Number of Participants With Treatment-Related Adverse Events AEs with Attribution of Possible Relation	26 Participants
Number of Participants With Treatment-Related Adverse Events AEs with Attribution of Probable Relation	16 Participants

SECONDARY outcome

Timeframe: Up to 25 months

Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment .

Outcome measures

Outcome measures
Measure	Pembrolizumab in Advanced HCC n=28 Participants Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.
Progression-Free Survival (PFS)	4.5 months Interval 2.0 to 7.0

SECONDARY outcome

Timeframe: Up to 25 months

Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive).

Outcome measures

Outcome measures
Measure	Pembrolizumab in Advanced HCC n=28 Participants Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.
Overall Survival (OS)	11 months Interval 7.0 to 19.0

SECONDARY outcome

Timeframe: Up to 2 years

Objective response rate (ORR) will be defined as the percentage of the patients with a confirmed complete or partial response (CR or PR),by MRI or CT scan as per RECIST 1.1 criteria. Complete response (CR), Disappearance of all target lesions; Partial response (PR), \>=30% decrease in sum of the longest diameter of target lesions; Overall response (OR) = (CR+PR.)Scans and assessments are performed every 9 weeks while on treatment up to 2 years if stable/responding, or up until time of disease progression.

Outcome measures

Outcome measures
Measure	Pembrolizumab in Advanced HCC n=28 Participants Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.
Objective Response Rate (ORR)	32 percentage of participants Interval 15.9 to 52.4

SECONDARY outcome

Timeframe: Up to 3 Years

Population: Median duration of response was not achieved for the participants by the end of study participation at the 3-year follow up visit.

Duration of Response (DoR) will be defined as the elapsed time from documented tumor response to documented disease progression.

Outcome measures

Outcome data not reported

Adverse Events

Pembrolizumab in Advanced HCC

Serious events: 7 serious events

Other events: 28 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab in Advanced HCC n=29 participants at risk Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.
Gastrointestinal disorders Abdominal pain	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Investigations Aspartate aminotransferase increased	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Cardiac disorders Atrial fibrillation	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Investigations Blood bilirubin increased	6.9% 2/29 • Number of events 2 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Gastrointestinal disorders Diarrhea	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
General disorders Fatigue	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Musculoskeletal and connective tissue disorders Myalgia	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Gastrointestinal disorders Nausea	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Investigations Neutrophil count decreased	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Gastrointestinal disorders Vomiting	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Investigations White blood cell decreased	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.

Other adverse events

Other adverse events
Measure	Pembrolizumab in Advanced HCC n=29 participants at risk Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.
Gastrointestinal disorders Abdominal distension	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Gastrointestinal disorders Abdominal pain	10.3% 3/29 • Number of events 3 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Renal and urinary disorders Acute kidney injury	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Investigations Alanine aminotransferase increased	34.5% 10/29 • Number of events 16 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Investigations Alkaline phosphatase increased	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Blood and lymphatic system disorders Anemia	6.9% 2/29 • Number of events 11 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Metabolism and nutrition disorders Anorexia	10.3% 3/29 • Number of events 3 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	10.3% 3/29 • Number of events 7 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Gastrointestinal disorders Ascites	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Investigations Aspartate aminotransferase increased	27.6% 8/29 • Number of events 12 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Investigations Blood bilirubin increased	31.0% 9/29 • Number of events 20 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
General disorders Chills	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Respiratory, thoracic and mediastinal disorders Cough	13.8% 4/29 • Number of events 4 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Investigations CPK increased	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Investigations Creatinine increased	6.9% 2/29 • Number of events 2 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Psychiatric disorders Depression	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Gastrointestinal disorders Diarrhea	31.0% 9/29 • Number of events 26 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Nervous system disorders Dizziness	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Gastrointestinal disorders Dyspepsia	6.9% 2/29 • Number of events 2 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
General disorders Edema limbs	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Endocrine disorders Endocrine disorders - Other	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Eye disorders Left Peri-orbital tenderness	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
General disorders Fatigue	37.9% 11/29 • Number of events 15 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
General disorders Fever	13.8% 4/29 • Number of events 4 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
General disorders Flu like symptoms	10.3% 3/29 • Number of events 3 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Gastrointestinal disorders Gastric ulcer	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
General disorders Edema	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Metabolism and nutrition disorders Hyperkalemia	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Endocrine disorders Hyperthyroidism	10.3% 3/29 • Number of events 3 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Metabolism and nutrition disorders Hypoalbuminemia	6.9% 2/29 • Number of events 2 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Endocrine disorders Hypothyroidism	20.7% 6/29 • Number of events 15 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Musculoskeletal and connective tissue disorders Joint effusion	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
General disorders Localized edema	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Musculoskeletal and connective tissue disorders Muscle cramps	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Musculoskeletal and connective tissue disorders Elbow tenderness	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Musculoskeletal and connective tissue disorders Knee pain	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Musculoskeletal and connective tissue disorders Myalgia	10.3% 3/29 • Number of events 6 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Skin and subcutaneous tissue disorders Nail loss	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Gastrointestinal disorders Nausea	17.2% 5/29 • Number of events 7 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Investigations Neutrophil count decreased	13.8% 4/29 • Number of events 9 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Gastrointestinal disorders Oral dysesthesia	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	6.9% 2/29 • Number of events 3 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Infections and infestations Papulopustular rash	6.9% 2/29 • Number of events 3 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Investigations Platelet count decreased	17.2% 5/29 • Number of events 24 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Skin and subcutaneous tissue disorders Pruritus	6.9% 2/29 • Number of events 2 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Skin and subcutaneous tissue disorders Rash acneiform	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	13.8% 4/29 • Number of events 6 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Skin and subcutaneous tissue disorders Skin Rash	10.3% 3/29 • Number of events 5 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Skin and subcutaneous tissue disorders Nail Change	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Skin and subcutaneous tissue disorders Psoriasis	10.3% 3/29 • Number of events 3 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Skin and subcutaneous tissue disorders Seborrheic Dermatitis	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Skin and subcutaneous tissue disorders Seborrheic Keratosis	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	6.9% 2/29 • Number of events 3 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Gastrointestinal disorders Vomiting	3.4% 1/29 • Number of events 1 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.
Investigations White blood cell decreased	13.8% 4/29 • Number of events 5 • 25 months Only treatment-emergent adverse events and serious adverse events are reported for this protocol. A treatment-emergent adverse event and serious adverse events (TEAE) are defined as any event that begins or worsens after the start of protocol treatment with a treating physician attribution of definite, probable or possible relation to treatment. One participant experienced two SAEs; one with attribution of possible relation, and the second with probable relation to study treatment.

Additional Information

Lynn G. Feun, MD

University of Miami

Phone: 305-243-6606

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place