Trial Outcomes & Findings for Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer (NCT NCT00806286)

Last Updated: 2020-05-13

Results Overview

Progression-free survival (PFS) was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (based upon radiographic tumor assessments) or death. As per Response Evaluation Criteria for Solid Tumors v1.0, disease progression was characterized as confirmed complete response (CR) defined as disappearance of all target lesions, confirmed partial response (PR) defined as ≥30% decrease from baseline, stable disease (SD) defined as neither progressive disease (PD) nor PR, and PD defined as ≥20% increase from smallest sum of longest diameter recorded since treatment started.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

111 participants

Primary outcome timeframe

18 weeks postdose

Results posted on

2020-05-13

Participant Flow

A total of 108 participants who met all inclusion and no exclusion criteria were randomized to CS-7017 or placebo combined with carboplatin/paclitaxel in the Phase 2 portion study. Three participants were enrolled in the Safety portion and received CS-7017 combined with carboplatin/paclitaxel (cycles 1-6) or CS-7017 monotherapy (subsequent cycles).

Participant milestones

Participant milestones
Measure	CS7017+Carboplatin+Paclitaxel Participants who received CS-7017 by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	CS7017-matching Placebo+Carboplatin+Paclitaxel Participants who received CS-7017-matching placebo by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	Safety Portion Participants who received CS-7017 combined with carboplatin/paclitaxel (cycles 1-6) or CS-7017 monotherapy (subsequent cycles).
Overall Study STARTED	54	54	3
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	54	54	3

Reasons for withdrawal

Reasons for withdrawal
Measure	CS7017+Carboplatin+Paclitaxel Participants who received CS-7017 by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	CS7017-matching Placebo+Carboplatin+Paclitaxel Participants who received CS-7017-matching placebo by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	Safety Portion Participants who received CS-7017 combined with carboplatin/paclitaxel (cycles 1-6) or CS-7017 monotherapy (subsequent cycles).
Overall Study Adverse Event	5	2	0
Overall Study Disease progression	31	38	1
Overall Study Death	1	6	0
Overall Study Lost to Follow-up	0	1	0
Overall Study Withdrawal by Subject	8	3	1
Overall Study Physician Decision	2	2	0
Overall Study Due to a variety of reasons	7	2	1

Baseline Characteristics

Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CS7017+Carboplatin+Paclitaxel n=54 Participants Participants who received CS-7017 by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	CS7017-matching Placebo+Carboplatin+Paclitaxel n=54 Participants Participants who received CS-7017-matching placebo by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	Safety Portion n=3 Participants Participants who received CS-7017 combined with carboplatin/paclitaxel (cycles 1-6) or CS-7017 monotherapy (subsequent cycles).	Total n=111 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants	39 Participants n=7 Participants	1 Participants n=5 Participants	88 Participants n=4 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	15 Participants n=7 Participants	2 Participants n=5 Participants	23 Participants n=4 Participants
Age, Continuous	57.3 years STANDARD_DEVIATION 8.19 • n=5 Participants	59.4 years STANDARD_DEVIATION 10.60 • n=7 Participants	65.3 years STANDARD_DEVIATION 12.01 • n=5 Participants	58.4 years STANDARD_DEVIATION 9.49 • n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	17 Participants n=7 Participants	1 Participants n=5 Participants	31 Participants n=4 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	37 Participants n=7 Participants	2 Participants n=5 Participants	80 Participants n=4 Participants
Region of Enrollment Romania	22 Participants n=5 Participants	22 Participants n=7 Participants	0 Participants n=5 Participants	44 Participants n=4 Participants
Region of Enrollment United States	12 Participants n=5 Participants	12 Participants n=7 Participants	3 Participants n=5 Participants	27 Participants n=4 Participants
Region of Enrollment Poland	7 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	13 Participants n=4 Participants
Region of Enrollment India	13 Participants n=5 Participants	14 Participants n=7 Participants	0 Participants n=5 Participants	27 Participants n=4 Participants

PRIMARY outcome

Timeframe: 18 weeks postdose

Population: Progression-free survival rates were assessed in the Full Analysis Set.

Outcome measures

Outcome measures
Measure	CS7017+Carboplatin+Paclitaxel n=54 Participants Participants who received CS-7017 by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	CS7017-matching Placebo+Carboplatin+Paclitaxel n=54 Participants Participants who received CS-7017-matching placebo by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	Safety Portion Participants who received CS-7017 combined with carboplatin/paclitaxel (cycles 1-6) or CS-7017 monotherapy (subsequent cycles).
Percentage of Participants With Progression-Free Survival at 18 Weeks Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer	40.2 percentage of participants Interval 25.7 to 54.2	63.3 percentage of participants Interval 48.7 to 74.9	—

PRIMARY outcome

Timeframe: 18 weeks postdose

Population: Progression-free survival rates were assessed in the Full Analysis Set.

Progression-free survival (PFS) was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (based upon radiographic tumor assessments) or death. Disease progression was determined in accordance with the RECIST version 1.0 criteria.

Outcome measures

Outcome measures
Measure	CS7017+Carboplatin+Paclitaxel n=54 Participants Participants who received CS-7017 by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	CS7017-matching Placebo+Carboplatin+Paclitaxel n=54 Participants Participants who received CS-7017-matching placebo by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	Safety Portion Participants who received CS-7017 combined with carboplatin/paclitaxel (cycles 1-6) or CS-7017 monotherapy (subsequent cycles).
Percentage of Participants With Progression-Free Survival Based on Radiologic and Clinical Assessments and Death After Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer	37.9 percentage of participants Interval 23.5 to 52.1	63.3 percentage of participants Interval 48.7 to 74.9	—

SECONDARY outcome

Timeframe: Baseline to date of death, up to approximately 2 years postdose

Population: OS was assessed in the Full Analysis Set.

Overall survival (OS) is defined as the time from randomization to the date of death resulting from any cause.

Outcome measures

Outcome measures
Measure	CS7017+Carboplatin+Paclitaxel n=54 Participants Participants who received CS-7017 by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	CS7017-matching Placebo+Carboplatin+Paclitaxel n=54 Participants Participants who received CS-7017-matching placebo by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	Safety Portion Participants who received CS-7017 combined with carboplatin/paclitaxel (cycles 1-6) or CS-7017 monotherapy (subsequent cycles).
Summary of Kaplan-Meier Analysis of Overall Survival Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer	244.0 days Interval 158.0 to 353.0	292.0 days Interval 233.0 to 404.0	—

SECONDARY outcome

Timeframe: Baseline to disease progression, death, or withdrawal from study, up to approximately 2 years postdose

Population: Best overall response was assessed in the Full Analysis Set.

As per Response Evaluation Criteria for Solid Tumors v1.0, the best overall response was characterized as confirmed complete response (CR) defined as disappearance of all target lesions, confirmed partial response (PR) defined as ≥30% decrease from baseline, stable disease (SD) defined as neither progressive disease (PD) nor PR, and PD defined as ≥20% increase from smallest sum of longest diameter recorded since treatment started. Objective response rate (ORR) was defined as CR + PR.

Outcome measures

Outcome measures
Measure	CS7017+Carboplatin+Paclitaxel n=54 Participants Participants who received CS-7017 by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	CS7017-matching Placebo+Carboplatin+Paclitaxel n=54 Participants Participants who received CS-7017-matching placebo by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	Safety Portion Participants who received CS-7017 combined with carboplatin/paclitaxel (cycles 1-6) or CS-7017 monotherapy (subsequent cycles).
Number of Participants With Best Overall Tumor Response and Objective Response Rate Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Best Objective Response of SD or Better	29 Participants	42 Participants	—
Number of Participants With Best Overall Tumor Response and Objective Response Rate Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Confirmed complete response (CR)	0 Participants	0 Participants	—
Number of Participants With Best Overall Tumor Response and Objective Response Rate Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Confirmed partial response (PR)	11 Participants	16 Participants	—
Number of Participants With Best Overall Tumor Response and Objective Response Rate Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Objective response (Confirmed CR+PR)	11 Participants	16 Participants	—
Number of Participants With Best Overall Tumor Response and Objective Response Rate Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Stable disease (SD)	11 Participants	18 Participants	—
Number of Participants With Best Overall Tumor Response and Objective Response Rate Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Progressive disease (PD)	17 Participants	5 Participants	—
Number of Participants With Best Overall Tumor Response and Objective Response Rate Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Unknown	8 Participants	7 Participants	—

SECONDARY outcome

Timeframe: Baseline up to approximately 2 years postdose

Population: Treatment-emergent adverse events were assessed in the Safety Population.

Outcome measures

Outcome measures
Measure	CS7017+Carboplatin+Paclitaxel n=54 Participants Participants who received CS-7017 by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	CS7017-matching Placebo+Carboplatin+Paclitaxel n=54 Participants Participants who received CS-7017-matching placebo by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	Safety Portion n=3 Participants Participants who received CS-7017 combined with carboplatin/paclitaxel (cycles 1-6) or CS-7017 monotherapy (subsequent cycles).
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Pancytopenia	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Thrombocytopenia	5 Participants	4 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Mouth haemorrhage	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Nausea	5 Participants	3 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer General Disorders & Administration Site Conditions	34 Participants	16 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Asthenia	2 Participants	3 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Hypoaesthesia oral	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Melaena	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Pancreatitis	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Stomatitis	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Vomiting	2 Participants	2 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Any TEAE	42 Participants	25 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Blood and Lymphatic System Disorders	10 Participants	11 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Anaemia	7 Participants	5 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Febrile neutropenia	2 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Leukopenia	1 Participants	2 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Lymphopenia	0 Participants	2 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Neutropenia	2 Participants	3 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Cardiac Disorders	2 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Acute myocardial infarction	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Palpitations	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Gastrointestinal Disorders	10 Participants	7 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Abdominal pain	1 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Abdominal pain upper	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Constipation	1 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Diarrhoea	1 Participants	5 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Dry mouth	1 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Dyspepsia	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Gastrooesophageal reflux disease	2 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Chest pain	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Chills	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Edema event	31 Participants	12 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Fatigue or Asthenia event	12 Participants	9 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Fatigue	11 Participants	7 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Generalised oedema	2 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Localised oedema	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Malaise	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Oedema	5 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Oedema peripheral	14 Participants	8 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Pyrexia	1 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Immune System Disorders	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Hypersensitivity	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Infections and Infestations	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Infection	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Investigations	16 Participants	7 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Alanine aminotransferase increased	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Aspartate aminotransferase increased	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Blood alkaline phosphatase increased	0 Participants	2 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Blood creatinine increased	2 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Transaminases increased	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Weight decreased	1 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Weight increased	15 Participants	3 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Metabolism and Nutrition Disorders	10 Participants	11 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Anorexia	5 Participants	6 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Dehydration	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Fluid retention	2 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Hypercholesterolaemia	4 Participants	1 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Hyperglycaemia	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Hypermagnesaemia	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Hypertriglyceridaemia	3 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Hypocalcaemia	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Hyponatraemia	0 Participants	2 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Musculoskeletal and Connective Tissue Disorders	1 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Bone pain	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Joint swelling	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Nervous System Disorders	2 Participants	3 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Dizziness	1 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Dysgeusia	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Guillain-Barre Syndrome	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Neuropathy peripheral	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Paraesthesia	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Renal and Urinary Disorders	2 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Haematuria	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Urinary retention	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Respiratory, Thoracic, and Mediastinal Disorders	12 Participants	2 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Cough	2 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Dyspnoea	4 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Haemoptysis	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Pleural effusion	5 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Pleurisy	2 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Pulmonary congestion	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Respiratory distress	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Wheezing	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Skin and Subcutaneous Tissue Disorders	6 Participants	3 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Acne	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Alopecia	1 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Pruritus	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Rash	0 Participants	2 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Rash erythematous	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Skin lesion	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Swelling face	3 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Vascular Disorders	1 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Hypotension	0 Participants	1 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer Pallor	1 Participants	0 Participants	0 Participants

Adverse Events

CS7017+Carboplatin+Paclitaxel

Serious events: 27 serious events

Other events: 53 other events

Deaths: 8 deaths

CS7017-matching Placebo+Carboplatin+Paclitaxel

Serious events: 29 serious events

Other events: 53 other events

Deaths: 14 deaths

Safety Portion

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo

Phone: 908-992-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	CS7017+Carboplatin+Paclitaxel n=54 participants at risk Participants who received CS-7017 by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	CS7017-matching Placebo+Carboplatin+Paclitaxel n=54 participants at risk Participants who received CS-7017-matching placebo by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	Safety Portion n=3 participants at risk Participants who received CS-7017 combined with carboplatin/paclitaxel (cycles 1-6) or CS-7017 monotherapy (subsequent cycles).
Blood and lymphatic system disorders Anaemia	9.3% 5/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	11.1% 6/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	9.3% 5/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	3.7% 2/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Blood and lymphatic system disorders Neutropenia	3.7% 2/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	7.4% 4/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Blood and lymphatic system disorders Pancytopenia	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	3.7% 2/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Cardiac disorders Acute myocardial infarction	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Cardiac disorders Atrial flutter	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 1/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	7.4% 4/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Gastrointestinal disorders Gastrointestinal toxicity	3.7% 2/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Gastrointestinal disorders Nausea	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Gastrointestinal disorders Pancreatitis	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Gastrointestinal disorders Vomiting	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	5.6% 3/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Asthenia	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Chest pain	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Death	3.7% 2/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	3.7% 2/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Disease progression	7.4% 4/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	13.0% 7/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Edema event	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Fatigue or Asthenia event	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Generalised oedema	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Pain	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Pyrexia	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	5.6% 3/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Hepatobiliary disorders Hepatic failure	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Infections and infestations Febrile infection	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Infections and infestations Osteomyelitis	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Infections and infestations Pneumonia	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	3.7% 2/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Investigations Bacteria stool identified	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Metabolism and nutrition disorders Anorexia	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Metabolism and nutrition disorders Dehydration	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 1/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.

Other adverse events
Measure	CS7017+Carboplatin+Paclitaxel n=54 participants at risk Participants who received CS-7017 by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	CS7017-matching Placebo+Carboplatin+Paclitaxel n=54 participants at risk Participants who received CS-7017-matching placebo by mouth (PO) approximately every 12 hours combined with carboplatin and paclitaxel administered IV once every 3 weeks (Day 1 each cycle).	Safety Portion n=3 participants at risk Participants who received CS-7017 combined with carboplatin/paclitaxel (cycles 1-6) or CS-7017 monotherapy (subsequent cycles).
Blood and lymphatic system disorders Anaemia	74.1% 40/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	50.0% 27/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	100.0% 3/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	9.3% 5/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	3.7% 2/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 1/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Blood and lymphatic system disorders Leukopenia	22.2% 12/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	16.7% 9/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	66.7% 2/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	7.4% 4/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Blood and lymphatic system disorders Neutropenia	27.8% 15/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	40.7% 22/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	66.7% 2/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	31.5% 17/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 18/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	66.7% 2/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Cardiac disorders Tachycardia	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	3.7% 2/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 1/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Gastrointestinal disorders Abdominal pain	5.6% 3/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	5.6% 3/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 1/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Gastrointestinal disorders Abdominal pain upper	5.6% 3/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	7.4% 4/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Gastrointestinal disorders Constipation	16.7% 9/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	14.8% 8/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 1/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Gastrointestinal disorders Diarrhoea	24.1% 13/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	24.1% 13/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Gastrointestinal disorders Nausea	33.3% 18/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	14.8% 8/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	66.7% 2/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Gastrointestinal disorders Vomiting	14.8% 8/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	22.2% 12/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Asthenia	14.8% 8/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	13.0% 7/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Chest pain	16.7% 9/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	18.5% 10/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Chills	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 1/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Disease progression	7.4% 4/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	13.0% 7/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Edema event	59.3% 32/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	24.1% 13/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	100.0% 3/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Fatigue or Asthenia event	44.4% 24/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	37.0% 20/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	100.0% 3/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Fatigue	33.3% 18/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	25.9% 14/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	100.0% 3/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Generalised oedema	3.7% 2/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 1/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Malaise	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 1/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Oedema	9.3% 5/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	3.7% 2/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Oedema peripheral	27.8% 15/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	16.7% 9/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Pain	7.4% 4/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	3.7% 2/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
General disorders Pyrexia	9.3% 5/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	18.5% 10/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	5.6% 3/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Infections and infestations Bronchitis	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 1/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Infections and infestations Pneumonia	5.6% 3/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	3.7% 2/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Infections and infestations Upper respiratory tract infection	1.9% 1/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 1/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	3.7% 2/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 1/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Investigations Blood alkaline phosphatase increased	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	5.6% 3/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 1/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Investigations Protein total decreased	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 1/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Investigations Red blood cell sedimentation rate increased	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 1/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Investigations Weight decreased	3.7% 2/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	11.1% 6/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	0.00% 0/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Investigations Weight increased	29.6% 16/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	5.6% 3/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	66.7% 2/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Metabolism and nutrition disorders Anorexia	16.7% 9/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	18.5% 10/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 1/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Metabolism and nutrition disorders Dehydration	5.6% 3/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	3.7% 2/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 1/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
Metabolism and nutrition disorders Hypercholesterolaemia	9.3% 5/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	3.7% 2/54 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.	33.3% 1/3 • Treatment-emergent adverse events were collected from baseline to the end of study assessment, approximately 2 years post dose. An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.