Trial Outcomes & Findings for A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia (NCT NCT03873493)

Last Updated: 2022-12-19

Results Overview

ORR is defined as the percentage of participants achieving complete remission (CR), CR with incomplete bone marrow recovery (CRi), or partial remission (PR) as their best response per investigator assessment based on the T-PLL consensus criteria 2019. CR: All of the following response criteria must be met: Group A: * all lymph nodes \< 1 cm; * spleen \< 13 cm; * no constitutional symptoms; * circulating lymphocyte count \< 4 × 10\^9/L; * bone marrow T-PLL cells \< 5% of mononuclear cells; * no other specific site involvement Group B: * platelets ≥ 100 × 10\^9 /L; * hemoglobin ≥ 11.0 g/dL; * neutrophils ≥ 1.5 × 10\^9 /L. CRi: All of the CR response criteria in Group A met; at least 1 parameter in Group B not achieved, unrelated to T-PLL, but related to drug toxicity. PR: At least 2 of the parameters in Group A and 1 parameter in Group B need to improve if previously abnormal. If only 1 parameter of both Groups A and B is abnormal prior to therapy, only 1 parameter needs to improve.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for ORR assessment

Results posted on

2022-12-19

Participant Flow

In total, 16 adults with relapsed or refractory T-cell prolymphocytic leukemia (R/R T-PLL) were screened, and 14 participants were enrolled across 10 sites in 7 countries (Australia, France, Germany, Italy, Netherlands, United Kingdom, and United States).

This study was planned as an adaptive 2-stage design with Stage 1 to enroll 14 participants and Stage 2 to enroll up to an additional 23 participants based on the number of responders in Stage 1. Results from Stage 1 met the protocol-defined stopping rules, hence Stage 2 was not opened for enrollment. Stage 1 was completed as planned. For one participant "study terminated by sponsor" was entered as study discontinuation reason by mistake.

Participant milestones

Participant milestones
Measure	Venetoclax + Ibrutinib Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.
Overall Study STARTED	14
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Venetoclax + Ibrutinib Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.
Overall Study Withdrawal by Subject	1
Overall Study Death	9
Overall Study Lost to Follow-up	1
Overall Study Study Terminated by Sponsor	1
Overall Study Other	2

Baseline Characteristics

A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Venetoclax + Ibrutinib n=14 Participants Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.
Age, Continuous	66.8 years STANDARD_DEVIATION 9.74 • n=93 Participants
Age, Customized < 40 years	0 Participants n=93 Participants
Age, Customized 40 - < 65 years	5 Participants n=93 Participants
Age, Customized ≥ 65 years	9 Participants n=93 Participants
Sex: Female, Male Female	8 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Disease Duration	3.229 years STANDARD_DEVIATION 3.2134 • n=93 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 (Fully active)	7 Participants n=93 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1 (Restricted activity but ambulatory and able to work)	6 Participants n=93 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 2 (Ambulatory but unable to work)	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for ORR assessment

Population: The full analysis set includes all participants who received at least 1 dose of study drug (either venetoclax or ibrutinib).

Outcome measures

Outcome measures
Measure	Venetoclax + Ibrutinib n=14 Participants Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.
Overall Response Rate (ORR)	7.1 percentage of participants Interval 0.2 to 33.9

SECONDARY outcome

Timeframe: From first dose of study drug to end of study; median time on study was 30.1 weeks.

Population: Full analysis set

Progression-free survival is defined as the time from the date of first dose of any study drug to the date of earliest disease progression or death. PFS was calculated using Kaplan-Meier methods. Response was assessed by the investigator based on the T-PLL consensus criteria 2019. Progressive disease (PD) is defined as meeting at least one of the criteria of Group A or Group B below: Group A: * lymph nodes increase in \> 20% in sum of long-axis diameters of up to 3 target lesions (SLD) from nadir; * spleen increase ≥ 50% in vertical length beyond normal from baseline; * circulating lymphocyte count increase ≥ 50% from baseline; * appearance of a new lesion; Group B: * platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity); * hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL; * neutrophils decrease of ≥ 50% from baseline due to T-PLL.

Outcome measures

Outcome measures
Measure	Venetoclax + Ibrutinib n=14 Participants Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.
Progression-Free Survival (PFS)	2.7 months Interval 1.2 to 5.3

SECONDARY outcome

Timeframe: From first dose of study drug to end of study; median time on study was 30.1 weeks.

Population: Full analysis set participants with a best overall response of CR, CRi, or PR

Duration of response is defined for participants who achieved a best overall response of CR, CRi, or PR as the time from the date of first response (CR, CRi, or PR) to the earliest date of disease progression or death. DOR was calculated using Kaplan-Meier methods. Response was assessed by the investigator based on the T-PLL consensus criteria 2019. Progressive disease is defined as meeting at least one of the criteria of Group A or Group B below: Group A: * lymph nodes increase in \> 20% in SLD from nadir; * spleen increase ≥ 50% in vertical length beyond normal from baseline; * circulating lymphocyte count increase ≥ 50% from baseline; * appearance of a new lesion; Group B: * platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity); * hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL; * neutrophils decrease of ≥ 50% from baseline due to T-PLL.

Outcome measures

Outcome measures
Measure	Venetoclax + Ibrutinib n=1 Participants Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.
Duration of Response (DOR)	4.6 months Interval 4.6 to 4.6

SECONDARY outcome

Timeframe: From first dose of study drug to end of study; median time on study was 30.1 weeks.

Population: Full analysis set

Time to progression is defined as the time from the date of the participant's first dose of any study drug to the date of earliest disease progression. TTP was calculated using Kaplan-Meier methods. Clinical response (laboratory and physical examination assessments) was assessed by the investigator according to the T-PLL consensus criteria 2019. Progressive disease is defined as meeting at least one of the criteria of Group A or Group B below: Group A: * lymph nodes increase in \> 20% in SLD from nadir; * spleen increase ≥ 50% in vertical length beyond normal from baseline; * circulating lymphocyte count increase ≥ 50% from baseline; * appearance of a new lesion; Group B: * platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity); * hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL; * neutrophils decrease of ≥ 50% from baseline due to T-PLL.

Outcome measures

Outcome measures
Measure	Venetoclax + Ibrutinib n=14 Participants Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.
Time to Progression (TTP)	2.7 months Interval 1.2 to 5.3

SECONDARY outcome

Timeframe: From first dose of study drug to end of study; median time on study was 30.1 weeks.

Population: Full analysis set

Event-free survival is defined as time from participant's first dose of any study drug to the date of earliest disease progression, death, or start of a new anti-T-PLL therapy. EFS was calculated using Kaplan-Meier methods. Clinical response (laboratory and physical examination assessments) was assessed by the investigator according to the T-PLL consensus criteria 2019. Progressive disease is defined as meeting at least one of the criteria of Group A or Group B below: Group A: * lymph nodes increase in \> 20% in SLD from nadir; * spleen increase ≥ 50% in vertical length beyond normal from baseline; * circulating lymphocyte count increase ≥ 50% from baseline; * appearance of a new lesion; Group B: * platelet count decrease of ≥ 50% from baseline due to T-PLL (not due to drug toxicity); * hemoglobin decrease of ≥ 2 g/dL from baseline due to T-PLL; * neutrophils decrease of ≥ 50% from baseline due to T-PLL.

Outcome measures

Outcome measures
Measure	Venetoclax + Ibrutinib n=14 Participants Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.
Event-free Survival (EFS)	2.6 months Interval 0.6 to 5.3

SECONDARY outcome

Timeframe: Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for DCR assessment

Population: Full analysis set

DCR is defined as the percentage of participants who achieved CR, CRi, PR, or stable disease (SD) as best overall response per investigator assessment based on the T-PLL consensus criteria 2019. Stable disease is defined as meeting all of the following criteria for at least 3 months: * lymph nodes change of -29% to +20% in SLD; * spleen change of -49% to +49% beyond normal from baseline; * circulating lymphocyte count \> 30 × 10\^9 /L or change of -49% to +49%; * platelet count change of -49% to +49%; * hemoglobin \< 11.0 g/dL or change \< 50% from baseline or change \< 2 g/dL; * neutrophils change of -49% to +49%.

Outcome measures

Outcome measures
Measure	Venetoclax + Ibrutinib n=14 Participants Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.
Disease Control Rate (DCR)	28.6 percentage of participants Interval 8.4 to 58.1

SECONDARY outcome

Timeframe: From first dose of study drug to end of study; median time on study was 30.1 weeks.

Population: Full analysis set

Overall survival is defined as the time from the date of the participant's first dose of any study drug to death from any cause. OS was calculated using Kaplan-Meier methods.

Outcome measures

Outcome measures
Measure	Venetoclax + Ibrutinib n=14 Participants Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.
Overall Survival (OS)	7.3 months Interval 1.6 to 10.9

SECONDARY outcome

Timeframe: From first dose of study drug to end of study; median time on study was 30.1 weeks.

Population: Participants who were transplant-naive and achieved CR. No participants achieved a CR to be eligible for transplant.

Participants eligible for autologous or allogeneic transplantation were transplant-naïve participants who achieved CR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks)

Population: All participants who received at least 1 dose of study drug (either venetoclax or ibrutinib)

An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are any event with onset after the first dose of study drug and no more than 30 days after the last dose of study drug. A serious AE was an event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or an important medical event requiring medical or surgical intervention to prevent a serious outcome. The Investigator rated the severity of each AE according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening and grade 5 = death. The Investigator assessed the relationship of the AE to the use of study drug.

Outcome measures

Outcome measures
Measure	Venetoclax + Ibrutinib n=14 Participants Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.
Number of Participants With Treatment-emergent Adverse Events (TEAE) Any adverse event	14 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) AE with NCI-CTCAE toxicity Grade 3, 4, or 5	11 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Serious adverse event	8 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) AE leading to venetoclax discontinuation, incl PD	11 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) AE leading to venetoclax interruption	9 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) AE leading to venetoclax reduction	2 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) AE with reasonable possibility related to venetoclax	10 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) AE leading to ibrutinib discontinuation, incl PD	11 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) AE leading to ibrutinib interruption	10 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) AE leading to ibrutinib reduction	1 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) AE with reasonable possibility related to ibrutinib	13 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Serious AE with reasonable possibility related to venetoclax	3 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Serious AE with reasonable possibility related to ibrutinib	4 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) AE leading to death	5 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) All deaths	10 Participants

Adverse Events

Venetoclax + Ibrutinib

Serious events: 8 serious events

Other events: 14 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Venetoclax + Ibrutinib n=14 participants at risk Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.
Blood and lymphatic system disorders ANAEMIA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Blood and lymphatic system disorders NEUTROPENIA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Gastrointestinal disorders NAUSEA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
General disorders DISEASE PROGRESSION	28.6% 4/14 • Number of events 5 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
General disorders EUTHANASIA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Infections and infestations ASPERGILLUS INFECTION	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Infections and infestations INFECTION	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Infections and infestations OROPHARYNGEAL CANDIDIASIS	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Musculoskeletal and connective tissue disorders FACET JOINT SYNDROME	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT NEOPLASM PROGRESSION	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT PLEURAL EFFUSION	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Renal and urinary disorders RENAL TUBULAR DISORDER	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Renal and urinary disorders URINARY RETENTION	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Vascular disorders PHLEBITIS	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).

Other adverse events

Other adverse events
Measure	Venetoclax + Ibrutinib n=14 participants at risk Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.
Blood and lymphatic system disorders ANAEMIA	21.4% 3/14 • Number of events 4 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Blood and lymphatic system disorders NEUTROPENIA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Cardiac disorders ATRIAL FIBRILLATION	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Cardiac disorders TACHYCARDIA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Ear and labyrinth disorders HYPOACUSIS	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Ear and labyrinth disorders MIDDLE EAR EFFUSION	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Endocrine disorders ANDROGEN DEFICIENCY	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Eye disorders EYE SWELLING	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Eye disorders LACRIMATION INCREASED	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Gastrointestinal disorders ABDOMINAL PAIN UPPER	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Gastrointestinal disorders CONSTIPATION	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Gastrointestinal disorders DIARRHOEA	57.1% 8/14 • Number of events 11 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Gastrointestinal disorders DYSPEPSIA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Gastrointestinal disorders DYSPHAGIA	7.1% 1/14 • Number of events 3 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Gastrointestinal disorders GLOSSODYNIA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Gastrointestinal disorders MELAENA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Gastrointestinal disorders NAUSEA	42.9% 6/14 • Number of events 7 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Gastrointestinal disorders PANCREATIC STEATOSIS	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Gastrointestinal disorders STOMATITIS	7.1% 1/14 • Number of events 2 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Gastrointestinal disorders TONGUE ERUPTION	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Gastrointestinal disorders VOMITING	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
General disorders ASTHENIA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
General disorders CATHETER SITE PAIN	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
General disorders COMPLICATION ASSOCIATED WITH DEVICE	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
General disorders DISEASE PROGRESSION	35.7% 5/14 • Number of events 5 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
General disorders FATIGUE	21.4% 3/14 • Number of events 3 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
General disorders OEDEMA PERIPHERAL	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Hepatobiliary disorders HYPERPLASTIC CHOLECYSTOPATHY	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Infections and infestations CELLULITIS	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Infections and infestations ESCHERICHIA URINARY TRACT INFECTION	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Infections and infestations FOLLICULITIS	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Infections and infestations GASTROENTERITIS	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Infections and infestations INFECTION	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Infections and infestations NASOPHARYNGITIS	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Infections and infestations ORAL CANDIDIASIS	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Infections and infestations PARVOVIRUS B19 INFECTION	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Infections and infestations RHINITIS	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Infections and infestations RHINOVIRUS INFECTION	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Infections and infestations TONSILLITIS	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Infections and infestations URINARY TRACT INFECTION	14.3% 2/14 • Number of events 3 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Injury, poisoning and procedural complications CONTUSION	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Injury, poisoning and procedural complications FALL	7.1% 1/14 • Number of events 2 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Injury, poisoning and procedural complications WOUND	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Investigations BLOOD BILIRUBIN INCREASED	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Investigations BLOOD CREATININE INCREASED	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Investigations LYMPHOCYTE COUNT INCREASED	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Investigations MAGNETIC RESONANCE IMAGING HEAD ABNORMAL	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Investigations NEUTROPHIL COUNT DECREASED	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Investigations PLATELET COUNT DECREASED	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Investigations WEIGHT DECREASED	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Investigations WHITE BLOOD CELL COUNT DECREASED	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Metabolism and nutrition disorders DECREASED APPETITE	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Metabolism and nutrition disorders FOLATE DEFICIENCY	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Metabolism and nutrition disorders HYPERGLYCAEMIA	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Metabolism and nutrition disorders HYPERKALAEMIA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Metabolism and nutrition disorders HYPERPHOSPHATAEMIA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Metabolism and nutrition disorders HYPOALBUMINAEMIA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Metabolism and nutrition disorders HYPOCALCAEMIA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Metabolism and nutrition disorders HYPOKALAEMIA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Metabolism and nutrition disorders HYPOMAGNESAEMIA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Metabolism and nutrition disorders HYPONATRAEMIA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Metabolism and nutrition disorders HYPOPHOSPHATAEMIA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Metabolism and nutrition disorders TUMOUR LYSIS SYNDROME	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Musculoskeletal and connective tissue disorders ARTHRALGIA	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Musculoskeletal and connective tissue disorders BACK PAIN	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LIPOMA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Nervous system disorders CEREBRAL ATROPHY	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Nervous system disorders CEREBRAL INFARCTION	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Nervous system disorders DIZZINESS	21.4% 3/14 • Number of events 3 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Nervous system disorders HEADACHE	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Nervous system disorders MEMORY IMPAIRMENT	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Product Issues DEVICE FAILURE	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Psychiatric disorders INSOMNIA	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Renal and urinary disorders BLADDER DIVERTICULUM	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Renal and urinary disorders URINARY INCONTINENCE	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Respiratory, thoracic and mediastinal disorders COUGH	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Respiratory, thoracic and mediastinal disorders DYSPNOEA	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Respiratory, thoracic and mediastinal disorders EPISTAXIS	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Respiratory, thoracic and mediastinal disorders NASAL ULCER	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Skin and subcutaneous tissue disorders ERYTHEMA	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Skin and subcutaneous tissue disorders PETECHIAE	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Skin and subcutaneous tissue disorders PRURITUS	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Skin and subcutaneous tissue disorders RASH	21.4% 3/14 • Number of events 3 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Skin and subcutaneous tissue disorders SKIN LESION	7.1% 1/14 • Number of events 2 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Vascular disorders ARTERIOSCLEROSIS	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).
Vascular disorders HYPOTENSION	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment through the end of study; median time on study was 30.1 weeks. Adverse events are reported from first dose of study drug up to 30 days after last dose; median time on treatment was 13.86 weeks (range 1.0 to 44.4 weeks).

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