Trial Outcomes & Findings for Evaluation of the Safety and Tolerability of TAK-228 With TAK-117 and Paclitaxel in Advanced Solid Tumors (NCT NCT03154294)

Last Updated: 2024-07-26

Results Overview

DLT is defined as any death not clearly due to underlying disease or extraneous causes; critical liver injury by Hy's Law; grade 3 or higher toxicity (with certain exceptions); inability to administer at least 75% of planned doses of TAK-228 within Cycle 1, due to study drug-related toxicity and any other clinically significant occurrence that the investigator and sponsor agree would place patients at an undue safety risk.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

19 participants

Primary outcome timeframe

30 days

Results posted on

2024-07-26

Participant Flow

Participants took part in this study at Avera Cancer Institute in Sioux Falls, South Dakota, United States from July 2017 to April 2020.

A total of 19 participants with a diagnosis of an advanced solid tumor malignancies were enrolled in this study.

Participant milestones

Participant milestones
Measure	Cohort 1 Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 100mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 2 Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 3 Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 4 Paclitaxel 80mg/m Day 1, Day 8, Day 15 TAK-228 3mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 5 Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 4mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25
Overall Study STARTED	4	3	3	6	3
Overall Study COMPLETED	4	3	3	4	2
Overall Study NOT COMPLETED	0	0	0	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=4 Participants Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 100mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 2 n=3 Participants Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 3 n=3 Participants Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 4 n=6 Participants Paclitaxel 80mg/m Day 1, Day 8, Day 15 TAK-228 3mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 5 n=3 Participants Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 4mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants	0 Participants n=19 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=4 Participants	2 Participants n=3 Participants	2 Participants n=3 Participants	4 Participants n=6 Participants	1 Participants n=3 Participants	11 Participants n=19 Participants
Age, Categorical >=65 years	2 Participants n=4 Participants	1 Participants n=3 Participants	1 Participants n=3 Participants	2 Participants n=6 Participants	2 Participants n=3 Participants	8 Participants n=19 Participants
Age, Continuous	65.25 years n=4 Participants	63.9 years n=3 Participants	61.8 years n=3 Participants	64.55 years n=6 Participants	66.6 years n=3 Participants	64.7 years n=19 Participants
Sex: Female, Male Female	4 Participants n=4 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants	6 Participants n=6 Participants	3 Participants n=3 Participants	19 Participants n=19 Participants
Sex: Female, Male Male	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants	0 Participants n=19 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	4 participants n=4 Participants	3 participants n=3 Participants	3 participants n=3 Participants	6 participants n=6 Participants	3 participants n=3 Participants	19 participants n=19 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Cohort 4 n=6 Participants Paclitaxel 80mg/m Day 1, Day 8, Day 15 TAK-228 3mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 5 n=3 Participants Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 4mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 1 n=4 Participants Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 100mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 2 n=3 Participants Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 3 n=3 Participants Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25
Number of Patients Who Developed Does-limiting Toxicity (DLT)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 27 months

Tumor objective response is assessed by CT or MRI and evaluated according to RECIST 1.1 response criteria. Complete Response (CR, disappearance of all target lesions), partial response (PR, \>= 30% decrease of target lesions) and stable disease (SD, either the increase of target lesion is less than 20% or not sufficient shrinkage to qualify for PR) are considered as beneficial clinical response.

Outcome measures

Outcome measures
Measure	Cohort 4 n=4 Participants Paclitaxel 80mg/m Day 1, Day 8, Day 15 TAK-228 3mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 5 n=3 Participants Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 4mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 1 n=4 Participants Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 100mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 2 n=1 Participants Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 3 n=3 Participants Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25
Number of Patients With Beneficial Clinical Response	3 Participants	2 Participants	3 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 27 months

Tumor objective response is assessed by CT or MRI and evaluated according to RECIST 1.1 response criteria. Complete Response (CR, disappearance of all target lesions) and partial response (PR, \>= 30% decrease of target lesions) are considered as beneficial clinical responses.

Outcome measures

Outcome measures
Measure	Cohort 4 n=4 Participants Paclitaxel 80mg/m Day 1, Day 8, Day 15 TAK-228 3mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 5 n=3 Participants Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 4mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 1 n=4 Participants Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 100mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 2 n=1 Participants Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 3 n=3 Participants Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25
Number of Patients With Tumor Objective Response	2 Participants	1 Participants	2 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 27 months

Tumor assessment according to RECIST 1.1 was performed at the end of the third cycle, and then every 12 week until study discontinuation or disease progression, whichever is later. For those patients without disease progression at the end of therapy, tumor assessments were undertaken every 3 month until either disease progression os observed or further anti-cancer treatment is initiated.

Outcome measures

Outcome measures
Measure	Cohort 4 n=3 Participants Paclitaxel 80mg/m Day 1, Day 8, Day 15 TAK-228 3mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 5 n=2 Participants Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 4mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 1 n=3 Participants Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 100mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 2 n=1 Participants Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 3 n=2 Participants Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25
Progression Free Survival (in Month)	10 months Interval 4.0 to 13.0	17 months Interval 7.0 to 27.0	10 months Interval 9.0 to 11.0	19 months Interval 19.0 to 19.0	6 months Interval 6.0 to 6.0

SECONDARY outcome

Timeframe: Baseline until date of death, assessed up to 43 months

All patients were contacted for survival status following study discontinuation at 4, 8, 12,18 and 24 months.

Outcome measures

Outcome measures
Measure	Cohort 4 n=6 Participants Paclitaxel 80mg/m Day 1, Day 8, Day 15 TAK-228 3mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 5 n=3 Participants Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 4mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 1 n=4 Participants Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 100mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 2 n=3 Participants Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 3 n=3 Participants Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25
Overall Survival	8 months Interval 3.0 to 29.0	23 months Interval 12.0 to 27.0	18 months Interval 12.0 to 20.0	9 months Interval 5.0 to 43.0	13 months Interval 5.0 to 26.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 27 months

Population: Only patients with genomic alteration at MTOR and PIK3CA are analyzed.

Outcome measures

Outcome measures
Measure	Cohort 4 n=2 Participants Paclitaxel 80mg/m Day 1, Day 8, Day 15 TAK-228 3mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 5 n=1 Participants Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 4mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 1 n=2 Participants Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 100mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 2 n=2 Participants Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 3 Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25
Number of Patients With MTOR and PI3K Alterations Who Had Clinical Favorable Responses.	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants

Adverse Events

Cohort 1

Serious events: 2 serious events

Other events: 4 other events

Deaths: 4 deaths

Cohort 2

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Cohort 3

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Cohort 4

Serious events: 6 serious events

Other events: 6 other events

Deaths: 6 deaths

Cohort 5

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 n=4 participants at risk Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 100mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 2 n=3 participants at risk Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 3 n=3 participants at risk Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 4 n=6 participants at risk Paclitaxel 80mg/m Day 1, Day 8, Day 15 TAK-228 3mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 5 n=3 participants at risk Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 4mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25
Blood and lymphatic system disorders Anemia	25.0% 1/4 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 9 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Endocrine disorders Hypothyroidism	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Fatigue	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders General disorder	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Worsened Ventral Hernia	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Mucositis oral	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Enterovesical fistula	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Periodontal disease	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Sepsis	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Activated partial thromboplastin time prolonged	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Alanine aminotransferase increased	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Neutrophil count decreased	50.0% 2/4 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • Number of events 4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Platelet count decreased	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations White blood cell decreased	50.0% 2/4 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 5 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypophosphatemia	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Proteinuria	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Urinary fistula	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hematoma	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hypertension	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Other adverse events
Measure	Cohort 1 n=4 participants at risk Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 100mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 2 n=3 participants at risk Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 3 n=3 participants at risk Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 4 n=6 participants at risk Paclitaxel 80mg/m Day 1, Day 8, Day 15 TAK-228 3mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25	Cohort 5 n=3 participants at risk Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 4mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25
Investigations Weight loss	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Anemia	25.0% 1/4 • Number of events 7 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 5 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 6/6 • Number of events 23 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • Number of events 16 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Palpitations	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Pericardial effusion	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Sinus bradycardia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Sinus tachycardia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Ear and labyrinth disorders Vertigo	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Endocrine disorders Hypothyroidism	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Chills	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Edema limbs	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Fatigue	50.0% 2/4 • Number of events 4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 5 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	83.3% 5/6 • Number of events 8 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • Number of events 6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Fever	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Gait disturbance	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Infusion related reaction	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Non-cardiac chest pain	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pain	25.0% 1/4 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Bloating	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Constipation	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Diarrhea	50.0% 2/4 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	83.3% 5/6 • Number of events 15 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • Number of events 7 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Worsened Ventral Hernia	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Hemorrhoids	50.0% 2/4 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Mucositis oral	75.0% 3/4 • Number of events 5 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	83.3% 5/6 • Number of events 11 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • Number of events 6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea	100.0% 4/4 • Number of events 7 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • Number of events 4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	83.3% 5/6 • Number of events 8 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • Number of events 10 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Vomiting	75.0% 3/4 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations COVID-19	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Lung infection	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Mucosal infection	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Sinusitis	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Skin infection	50.0% 2/4 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Upper respiratory infection	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Urinary tract infection	25.0% 1/4 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 4/6 • Number of events 6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Fracture	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Activated partial thromboplastin time prolonged	50.0% 2/4 • Number of events 7 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • Number of events 4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Alanine aminotransferase increased	50.0% 2/4 • Number of events 4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • Number of events 8 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Alkaline phosphatase increased	25.0% 1/4 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 5 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood bilirubin increased	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Creatinine increased	25.0% 1/4 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Neutrophil count decreased	75.0% 3/4 • Number of events 4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 10 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 7 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	83.3% 5/6 • Number of events 23 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • Number of events 12 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Platelet count decreased	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • Number of events 8 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 7 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations White blood cell decreased	100.0% 4/4 • Number of events 18 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • Number of events 15 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • Number of events 8 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	83.3% 5/6 • Number of events 32 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • Number of events 33 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Acidosis	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Anorexia	50.0% 2/4 • Number of events 5 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 5 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	83.3% 5/6 • Number of events 10 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • Number of events 5 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 7 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 5 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 2/4 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • Number of events 9 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • Number of events 5 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypocalcemia	50.0% 2/4 • Number of events 8 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 4/6 • Number of events 12 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypokalemia	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	83.3% 5/6 • Number of events 15 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • Number of events 9 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 10 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypophosphatemia	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	75.0% 3/4 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthritis	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Pain (Tailbone)	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	50.0% 2/4 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dizziness	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dysgeusia	50.0% 2/4 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dysphasia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Peripheral sensory neuropathy	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Sinus pain	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Tremor	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Anxiety	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Insomnia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Restlessness	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Bladder spasm	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Hematuria	75.0% 3/4 • Number of events 4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 4/6 • Number of events 5 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Proteinuria	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • Number of events 5 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 5 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Urinary incontinence	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	100.0% 3/3 • Number of events 4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • Number of events 5 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	50.0% 2/4 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Hoarseness	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Bloody Sputum	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Chest Congestion	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Sore throat	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Alopecia	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Dry skin	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • Number of events 4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	83.3% 5/6 • Number of events 9 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 2/3 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 2 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hot flashes	25.0% 1/4 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hypertension	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hypotension	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 1/3 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Thromboembolic event	0.00% 0/4 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • Number of events 1 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/3 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were collected up to 27 months. All-Cause Mortality was collected up to 43 months. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Dr. Casey Williams

Avera Cancer Institute

Phone: 605-322-3588

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place