Trial Outcomes & Findings for CPI-613 in Treating Patients With Advanced or Metastatic Bile Duct Cancer That Cannot Be Removed By Surgery (NCT NCT01766219)

NCT ID: NCT01766219

Last Updated: 2019-05-15

Results Overview

Estimated using Kaplan-Meier techniques.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: From the first dose of 6,8-bis(benzylthio)octanoic acid to death, assessed up to 4 years
• Results posted on: 2019-05-15

Participant Flow

Participant milestones

Measure	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 600/3,000 mg/m² Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1. Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment.	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 1,200/3,000 mg/m² Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1. Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 2,300 mg/m² Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV
Overall Study STARTED	11	2	4
Overall Study COMPLETED	11	2	4
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CPI-613 in Treating Patients With Advanced or Metastatic Bile Duct Cancer That Cannot Be Removed By Surgery

Baseline characteristics by cohort

Measure	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 2,300 mg/m² n=4 Participants Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 1,200/3,000 mg/m² n=2 Participants Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1. Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 600/3,000 mg/m² n=11 Participants Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1. Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	11 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants
Age, Continuous	52 years n=5 Participants	66 years n=7 Participants	62 years n=5 Participants	57 years n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants	17 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	4 participants n=5 Participants	2 participants n=7 Participants	11 participants n=5 Participants	17 participants n=4 Participants

PRIMARY outcome

Timeframe: From the first dose of 6,8-bis(benzylthio)octanoic acid to death, assessed up to 4 years

Estimated using Kaplan-Meier techniques.

Outcome measures

Measure	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 2,300 mg/m² n=4 Participants Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 1,200/3,000 mg/m² n=2 Participants Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1. Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 600/3,000 mg/m² n=11 Participants Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1. Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV
Overall Survival	4.7 months Interval 3.2 to 11.0	1.6 months Interval 0.95 to 2.3	3.94 months Interval 2.4 to 8.4

SECONDARY outcome

Timeframe: From the start of the treatment until disease progression, assessed up to 4 year

Using the RECIST version 1.1 as defined by patient with 95% confidence interval will be included. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note:the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study

Outcome measures

Measure	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 2,300 mg/m² n=4 Participants Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 1,200/3,000 mg/m² n=2 Participants Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1. Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 600/3,000 mg/m² n=11 Participants Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1. Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV
Response Rate Defined as Proportion of Patients With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) Stable Disease	0 participants	2 participants	2 participants
Response Rate Defined as Proportion of Patients With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) Progression	4 participants	0 participants	7 participants
Response Rate Defined as Proportion of Patients With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) Not Evaluable	0 participants	0 participants	2 participants

SECONDARY outcome

Timeframe: From the first dose of 6,8-bis(benzylthio)octanoic acid to disease progression (DP) or death due to any cause, assessed up to 4 years

Estimated using Kaplan-Meier techniques as well as RECIST 1.1. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note:the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 2,300 mg/m² n=4 Participants Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 1,200/3,000 mg/m² n=2 Participants Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1. Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 600/3,000 mg/m² n=11 Participants Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1. Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV
Progression-free Survival	1.6 months Interval 1.1 to 3.8	0 months Both participants in Arm 2 progressed at the exact same time, the statistician couldn't get a median and a confidence interval. A mean or 0.5589 and standard deviation of 0 was reported	2.5 months Interval 1.4 to 3.6

SECONDARY outcome

Timeframe: Up to 1 month completion of study treatment, assessed up to 1 year

Adverse events will be captured using the National Cancer Institute Common Terminology Criteria (NCI CTCAE) version 3.0

Outcome measures

Measure	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 2,300 mg/m² n=4 Participants Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 1,200/3,000 mg/m² n=2 Participants Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1. Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 600/3,000 mg/m² n=11 Participants Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1. Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV
Number of Participants With Adverse Events Using the National Cancer Institute Common Terminology Criteria	4 Participants	2 Participants	11 Participants

Adverse Events

Treatment (6,8-bis[Benzylthio]Octanoic Acid) 2,300 mg/m²

Serious events: 0 serious events

Other events: 4 other events

Deaths: 4 deaths

Treatment (6,8-bis[Benzylthio]Octanoic Acid) 1,200/3,000 mg/m²

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

Treatment (6,8-bis[Benzylthio]Octanoic Acid) 600/3,000 mg/m²

Serious events: 1 serious events

Other events: 11 other events

Deaths: 11 deaths

Serious adverse events

Measure	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 2,300 mg/m² n=4 participants at risk Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 1,200/3,000 mg/m² n=2 participants at risk Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1. Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 600/3,000 mg/m² n=11 participants at risk Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1. Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV
Renal and urinary disorders Chronic kidney disease	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Vascular disorders Hypotension	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Infections and infestations Sepsis	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.

Other adverse events

Measure	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 2,300 mg/m² n=4 participants at risk Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 1,200/3,000 mg/m² n=2 participants at risk Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1. Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV	Treatment (6,8-bis[Benzylthio]Octanoic Acid) 600/3,000 mg/m² n=11 participants at risk Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1. Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment. 6,8-bis(benzylthio)octanoic acid: Given IV
Gastrointestinal disorders Abdominal pain	50.0% 2/4 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	27.3% 3/11 • Number of events 3 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Investigations Activated partial thromboplastin time prolonged	50.0% 2/4 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	36.4% 4/11 • Number of events 4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Investigations Alanine amniotransferase increased	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	63.6% 7/11 • Number of events 7 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Investigations Alkaline phosphastase increased	100.0% 4/4 • Number of events 4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	100.0% 11/11 • Number of events 11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Blood and lymphatic system disorders Anemia	100.0% 4/4 • Number of events 4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	100.0% 2/2 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	100.0% 11/11 • Number of events 11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Anorexia	50.0% 2/4 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	72.7% 8/11 • Number of events 8 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Psychiatric disorders Anxiety	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Gastrointestinal disorders Ascites	50.0% 2/4 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	63.6% 7/11 • Number of events 7 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Investigations Aspartate aminotransferase increased	100.0% 4/4 • Number of events 4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	81.8% 9/11 • Number of events 9 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Musculoskeletal and connective tissue disorders Back pain	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	18.2% 2/11 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Investigations Blood bilirubin increased	75.0% 3/4 • Number of events 3 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	54.5% 6/11 • Number of events 6 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Infections and infestations Catheter related infection	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Investigations Cholesterol high	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Renal and urinary disorders Chronic kidney disease	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	100.0% 2/2 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	45.5% 5/11 • Number of events 5 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
General disorders Chills	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	18.2% 2/11 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Gastrointestinal disorders Diarrhea	75.0% 3/4 • Number of events 3 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	45.5% 5/11 • Number of events 5 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
General disorders Fatigue	75.0% 3/4 • Number of events 3 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	81.8% 9/11 • Number of events 9 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Investigations GGT increased	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Nervous system disorders Headache	50.0% 2/4 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Hepatobiliary disorders Hepatic hemorrhage	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Hepatobiliary disorders Cystic duct obstruction	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Hypercalcemia	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	18.2% 2/11 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Hyperglycemia	100.0% 4/4 • Number of events 4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	100.0% 2/2 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	54.5% 6/11 • Number of events 6 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Hypertriglyceridemia	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 4/4 • Number of events 4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	100.0% 2/2 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	81.8% 9/11 • Number of events 9 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Hyponatremia	75.0% 3/4 • Number of events 3 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	100.0% 2/2 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	63.6% 7/11 • Number of events 7 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Hypophosphatemia	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	36.4% 4/11 • Number of events 4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Investigations Lymphocyte count decreased	75.0% 3/4 • Number of events 3 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	100.0% 11/11 • Number of events 11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Gastrointestinal disorders Nausea	100.0% 4/4 • Number of events 4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	100.0% 2/2 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	72.7% 8/11 • Number of events 8 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Infections and infestations Pancreas infection	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Gastrointestinal disorders Pancreatitis	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Nervous system disorders Peripheral sensory neuropathy	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	27.3% 3/11 • Number of events 3 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Investigations Platelet count decreased	50.0% 2/4 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	45.5% 5/11 • Number of events 5 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Renal and urinary disorders Proteinuria	50.0% 2/4 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	18.2% 2/11 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Gastrointestinal disorders Vomiting	75.0% 3/4 • Number of events 3 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	54.5% 6/11 • Number of events 6 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Investigations White blood count decreased	50.0% 2/4 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	27.3% 3/11 • Number of events 3 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	36.4% 4/11 • Number of events 4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Cardiac disorders Atrial fibrillation	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Gastrointestinal disorders Constipation	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	36.4% 4/11 • Number of events 4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Investigations Creatinine increased	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	36.4% 4/11 • Number of events 4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	18.2% 2/11 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Gastrointestinal disorders Dysphagia	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	45.5% 5/11 • Number of events 5 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
General disorders Edema limbs	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	63.6% 7/11 • Number of events 7 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Investigations Electrocardiogram QT corrected interval prolonged	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	18.2% 2/11 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Infections and infestations Esophageal infection	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Psychiatric disorders Hallucinations	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Cardiac disorders Heart failure	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Hypoglycemia	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	27.3% 3/11 • Number of events 3 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Hypomagnesemia	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	81.8% 9/11 • Number of events 9 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Endocrine disorders Hypothyroidism	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	18.2% 2/11 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
General disorders Pain	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	100.0% 2/2 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	36.4% 4/11 • Number of events 4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	27.3% 3/11 • Number of events 3 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Renal and urinary disorders Oliguria	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Respiratory, thoracic and mediastinal disorders Sleep apnea	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Alkalosis	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Infections and infestations Biliary tract infection	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Gastrointestinal disorders Bloating	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Eye disorders Blurred vision	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Injury, poisoning and procedural complications Bruising	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	18.2% 2/11 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Gastrointestinal disorders Colitis	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Gastrointestinal disorders Colonic fistula	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Nervous system disorders Concentration impairment	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Psychiatric disorders Confusion	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	18.2% 2/11 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Psychiatric disorders Depression	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	27.3% 3/11 • Number of events 3 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Nervous system disorders Dizziness	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Nervous system disorders Dysgeusia	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	18.2% 2/11 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
General disorders Edema face	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
General disorders Edema trunk	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Eye disorders Eye pain	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
General disorders Fever	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	27.3% 3/11 • Number of events 3 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Gastrointestinal disorders Flatulence	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	18.2% 2/11 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
General disorders Gait disturbance	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Gastrointestinal disorders Diffuse abdominal tenderness	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	18.2% 2/11 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	45.5% 5/11 • Number of events 5 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Ear and labyrinth disorders Hearing impaired	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Renal and urinary disorders Hematuria	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Vascular disorders Hot flashes	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	18.2% 2/11 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Vascular disorders Hypertension	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	36.4% 4/11 • Number of events 4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Hypocalcemia	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	27.3% 3/11 • Number of events 3 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Infections and infestations Esophageal candidiasis	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Hepatobiliary disorders Biliary obstruction	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Hepatobiliary disorders Pancreatic duct stenosis	25.0% 1/4 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Psychiatric disorders Insomnia	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	27.3% 3/11 • Number of events 3 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Nervous system disorders Lethargy	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	18.2% 2/11 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Investigations Lipase increased	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Iron elevated	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Musculoskeletal and connective tissue disorders Muscle weakness, left side	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Musculoskeletal and connective tissue disorders Muscle weakness, right side	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Musculoskeletal and connective tissue disorders Muscle weakness, lower limb	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Musculoskeletal and connective tissue disorders Muscle weakness, trunk	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Musculoskeletal and connective tissue disorders Muscle weakness, upper limb	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
General disorders General body aches	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Nervous system disorders Nervous system disorders Other	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
General disorders Non-cardiac chest pain	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Obesity	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	18.2% 2/11 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Cardiac disorders Paroxysmal atrial tachycardia	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Vascular disorders Phlebitis	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Eye disorders Photophobia	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Vascular disorders Hypotension	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	50.0% 1/2 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/11 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Psychiatric disorders Decreased concentration	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	18.2% 2/11 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Cardiac disorders Sinus bradycardia	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Cardiac disorders Sinus tachycardia	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Infections and infestations Sinusitis	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Skin and subcutaneous tissue disorders Erythema, left extremity	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Skin and subcutaneous tissue disorders Petechia, right buttock	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Infections and infestations Shingles	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Ear and labyrinth disorders Tinnitus	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Weight gain	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Metabolism and nutrition disorders Weight loss	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	9.1% 1/11 • Number of events 1 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/4 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	0.00% 0/2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.	18.2% 2/11 • Number of events 2 • Up to 4 years All-Cause Mortality data, serious Adverse Events and Other (Not Including Serious) Adverse Events data were collected for 17 participants.

Additional Information

Caio Max Rocha Lima

Wake Forest University Health Sciences

Phone: 336-703-4246

Email: crochali@wakehealth.edu

Results disclosure agreements

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