Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) (NCT NCT03743064)

NCT ID: NCT03743064

Last Updated: 2024-06-26

Results Overview

This co-primary efficacy endpoint was mean change from baseline in body weight (kg) over 12 weeks in the anamorelin HCl group versus placebo group. Mean change was computed as sum of the changes from baseline over 12 weeks by the time of the last assessment (either week 12 or before in case of death), and then divided by the number of assessments (observed or imputed) from baseline up to the time of the last assessment.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 318 participants
• Primary outcome timeframe: Mean change from baseline over 12 weeks.
• Results posted on: 2024-06-26

Participant Flow

Patients were enrolled at a total of 49 study sites in Australia (2 sites), Belgium (2 sites), Croatia (3 sites), Germany (3 sites), Poland (5 sites), Romania (7 sites), Russia (10 sites), Ukraine (8 sites), and USA (9 sites). First Patient Enrollment (date of randomization) was on 06MAY2019.

The protocol had pre-defined criteria regarding health and medication requirements to begin study drug administration, and if the patient's status for these requirements changed between screening and Study Day 1, treatment could not be initiated.

Participant milestones

Measure	100 mg Anamorelin HCl 100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks	Placebo Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks
Overall Study STARTED	154	164
Overall Study Treated	154	164
Overall Study COMPLETED	83	90
Overall Study NOT COMPLETED	71	74

Reasons for withdrawal

Measure	100 mg Anamorelin HCl 100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks	Placebo Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks
Overall Study Adverse Event	7	9
Overall Study Death	25	28
Overall Study Lost to Follow-up	3	6
Overall Study Withdrawal by Subject	28	25
Overall Study Physician Decision	2	4
Overall Study Reported as "Other" in Clinical Study Report	6	2

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Measure	100 mg Anamorelin HCl n=154 Participants 100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks	Placebo n=164 Participants Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks	Total n=318 Participants Total of all reporting groups
Age, Continuous	64.0 Years STANDARD_DEVIATION 8.49 • n=5 Participants	63.6 Years STANDARD_DEVIATION 9.73 • n=7 Participants	63.8 Years STANDARD_DEVIATION 9.14 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	50 Participants n=7 Participants	92 Participants n=5 Participants
Sex: Female, Male Male	112 Participants n=5 Participants	114 Participants n=7 Participants	226 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	146 Participants n=5 Participants	156 Participants n=7 Participants	302 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White	148 Participants n=5 Participants	157 Participants n=7 Participants	305 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Romania	58 Participants n=5 Participants	59 Participants n=7 Participants	117 Participants n=5 Participants
Region of Enrollment Belgium	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment Ukraine	38 Participants n=5 Participants	34 Participants n=7 Participants	72 Participants n=5 Participants
Region of Enrollment Poland	11 Participants n=5 Participants	19 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment Australia	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Croatia	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Russia	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Region of Enrollment Germany	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Height	171.03 cm STANDARD_DEVIATION 8.690 • n=5 Participants	169.96 cm STANDARD_DEVIATION 9.164 • n=7 Participants	170.48 cm STANDARD_DEVIATION 8.940 • n=5 Participants
Weight	54.09 kg STANDARD_DEVIATION 7.029 • n=5 Participants	52.84 kg STANDARD_DEVIATION 7.925 • n=7 Participants	53.44 kg STANDARD_DEVIATION 7.519 • n=5 Participants
Body Mass Index	18.38 kg/m^2 STANDARD_DEVIATION 1.328 • n=5 Participants	18.16 kg/m^2 STANDARD_DEVIATION 1.579 • n=7 Participants	18.27 kg/m^2 STANDARD_DEVIATION 1.465 • n=5 Participants
Chemotherapy Line First Line	104 Participants n=5 Participants	104 Participants n=7 Participants	208 Participants n=5 Participants
Chemotherapy Line Second Line	36 Participants n=5 Participants	39 Participants n=7 Participants	75 Participants n=5 Participants
Chemotherapy Line Third Line	14 Participants n=5 Participants	21 Participants n=7 Participants	35 Participants n=5 Participants
Anti-cancer Treatment Immunotherapy	39 Participants n=5 Participants	46 Participants n=7 Participants	85 Participants n=5 Participants
Anti-cancer Treatment Non-immunotherapy	115 Participants n=5 Participants	118 Participants n=7 Participants	233 Participants n=5 Participants
5-IASS Score ≤10	102 Participants n=5 Participants	107 Participants n=7 Participants	209 Participants n=5 Participants
5-IASS Score >10	52 Participants n=5 Participants	57 Participants n=7 Participants	109 Participants n=5 Participants
NSCLC stage at study entry IIIA	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
NSCLC stage at study entry IIIB	30 Participants n=5 Participants	19 Participants n=7 Participants	49 Participants n=5 Participants
NSCLC stage at study entry IV	122 Participants n=5 Participants	143 Participants n=7 Participants	265 Participants n=5 Participants
NSCLC stage at study entry Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Body weight change within 6 months prior to screening	-10.03 percent change STANDARD_DEVIATION 6.177 • n=5 Participants	-10.86 percent change STANDARD_DEVIATION 6.612 • n=7 Participants	-10.46 percent change STANDARD_DEVIATION 6.408 • n=5 Participants

PRIMARY outcome

Timeframe: Mean change from baseline over 12 weeks.

Population: The Intent-to-Treat (ITT) Set included all randomized patients and was analyzed as per planned treatment.

This co-primary efficacy endpoint was mean change from baseline in body weight (kg) over 12 weeks in the anamorelin HCl group versus placebo group. Mean change was computed as sum of the changes from baseline over 12 weeks by the time of the last assessment (either week 12 or before in case of death), and then divided by the number of assessments (observed or imputed) from baseline up to the time of the last assessment.

Outcome measures

Measure	100 mg Anamorelin HCl n=154 Participants 100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks	Placebo n=164 Participants Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks
Mean Change From Baseline in Body Weight Over 12 Weeks	1.822 kg Standard Error 0.263	0.538 kg Standard Error 0.250

PRIMARY outcome

Timeframe: Mean change from baseline over 12 weeks.

Population: The ITT Set included all randomized patients and was analyzed as per planned treatment.

This co-primary efficacy endpoint was mean change from baseline in 5-IASS (points) over 12 weeks in the anamorelin HCl group versus placebo group. Mean change was computed as sum of the changes from baseline over 12 weeks by the time of the last assessment (either week 12 or before in case of death), and then divided by the number of assessments (observed or imputed) from baseline up to the time of the last assessment.

FAACT-A/CS (Functional Assessment Anorexia Cachexia Therapy) is a 12-item measure of patients' perceptions of anorexia/cachexia symptoms and concerns. From this questionnaire, the 5-item section referring to anorexia symptoms (i.e., "good appetite," "interest in food drops," "food tastes unpleasant," "get full quickly," and "difficulty eating rich/heavy foods") was used to assess 5-IASS. The range of possible scores is 0-20. Higher scores indicate lower levels of symptom burden.

Outcome measures

Measure	100 mg Anamorelin HCl n=154 Participants 100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks	Placebo n=164 Participants Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks
Mean Change From Baseline in 5-item Anorexia Symptom Subscale (5-IASS) Over 12 Weeks	3.432 score on a scale Standard Error 0.360	3.291 score on a scale Standard Error 0.342

SECONDARY outcome

Timeframe: Duration of treatment benefit from baseline over 12 weeks.

Population: The ITT Set included all randomized patients and was analyzed as per planned treatment.

The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in body weight of ≥0 kg.

Outcome measures

Measure	100 mg Anamorelin HCl n=154 Participants 100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks	Placebo n=164 Participants Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks
Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥0 kg)	8.859 weeks Standard Error 0.525	6.778 weeks Standard Error 0.496

SECONDARY outcome

Timeframe: Duration of treatment benefit from baseline over 12 weeks.

Population: The ITT Set included all randomized patients and was analyzed as per planned treatment.

The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in body weight of ≥1.5 kg.

Outcome measures

Measure	100 mg Anamorelin HCl n=154 Participants 100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks	Placebo n=164 Participants Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks
Duration in Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥1.5 kg)	5.490 weeks Standard Error 0.431	3.087 weeks Standard Error 0.409

SECONDARY outcome

Timeframe: Duration of treatment benefit from baseline over 12 weeks.

Population: The ITT Set included all randomized patients and was analyzed as per planned treatment.

The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in 5- IASS of ≥0 points.

Outcome measures

Measure	100 mg Anamorelin HCl n=154 Participants 100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks	Placebo n=164 Participants Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks
Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥0 Points)	9.470 weeks Standard Error 0.392	8.842 weeks Standard Error 0.370

SECONDARY outcome

Timeframe: Duration of treatment benefit from baseline over 12 weeks.

Population: The ITT Set included all randomized patients and was analyzed as per planned treatment.

The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in 5- IASS of ≥3 points.

Outcome measures

Measure	100 mg Anamorelin HCl n=154 Participants 100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks	Placebo n=164 Participants Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks
Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥3 Points)	5.143 weeks Standard Error 0.410	4.992 weeks Standard Error 0.387

Adverse Events

100 mg Anamorelin HCl

Serious events: 44 serious events

Other events: 114 other events

Deaths: 25 deaths

Placebo

Serious events: 46 serious events

Other events: 127 other events

Deaths: 28 deaths

Serious adverse events

Measure	100 mg Anamorelin HCl n=154 participants at risk 100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks	Placebo n=164 participants at risk Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks
Gastrointestinal disorders Intestinal ischaemia	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Gastrointestinal disorders Colitis	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Gastrointestinal disorders Diarrhoea	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	11.7% 18/154 • Number of events 18 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	11.6% 19/164 • Number of events 19 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	1.3% 2/154 • Number of events 2 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Infections and infestations Corona virus infection	1.9% 3/154 • Number of events 3 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	1.2% 2/164 • Number of events 2 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Infections and infestations Pneumonia	1.9% 3/154 • Number of events 3 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	1.8% 3/164 • Number of events 3 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Infections and infestations Cellulitis	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Infections and infestations Lung abscess	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Infections and infestations Clostridium difficile colitis	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Infections and infestations Febrile infection	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Infections and infestations Sepsis	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary Infarction	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Respiratory, thoracic and mediastinal disorders Respiratory tract haemorrhage	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Respiratory, thoracic and mediastinal disorders Pleura effusion	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	1.2% 2/164 • Number of events 2 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Blood and lymphatic system disorders Anaemia	2.6% 4/154 • Number of events 6 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	1.8% 3/164 • Number of events 3 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Blood and lymphatic system disorders Febrile neutropenia	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Blood and lymphatic system disorders Neutropenia	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	1.2% 2/164 • Number of events 2 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Cardiac disorders Cardiac disorder	1.3% 2/154 • Number of events 2 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Cardiac disorders Cardiac failure acute	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Cardiac disorders Atrial fibrillation	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Cardiac disorders Cardiac failure	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Nervous system disorders Cerebrovascular accident	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Nervous system disorders Peripheral sensorimotor neuropathy	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Nervous system disorders Seizure	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Nervous system disorders Ischaemic stroke	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Vascular disorders Deep vein thrombosis	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Vascular disorders Peripheral artery stenosis	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Vascular disorders Superior vena cava syndrome	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Metabolism and nutrition disorders Decreased appetite	0.65% 1/154 • Number of events 2 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Metabolism and nutrition disorders Hyponatraemia	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Metabolism and nutrition disorders Dehydration	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Gastrointestinal disorders Dysphagia	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Social circumstances Disability	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
General disorders Chest pain	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 2 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
General disorders Death	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
General disorders Pyrexia	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Hepatobiliary disorders Bile duct stone	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Investigations Blood potassium increased	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Investigations Troponin increased	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Psychiatric disorders Depression	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Renal and urinary disorders Acute kidney injury	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Renal and urinary disorders Renal failure	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 2 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.

Other adverse events

Measure	100 mg Anamorelin HCl n=154 participants at risk 100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks	Placebo n=164 participants at risk Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks
General disorders Asthenia	12.3% 19/154 • Number of events 24 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	13.4% 22/164 • Number of events 26 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
General disorders Chest Pain	8.4% 13/154 • Number of events 14 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	5.5% 9/164 • Number of events 10 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
General disorders Fatigue	4.5% 7/154 • Number of events 7 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	1.2% 2/164 • Number of events 2 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
General disorders Oedema Peripheral	4.5% 7/154 • Number of events 9 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	3.0% 5/164 • Number of events 8 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Gastrointestinal disorders Nausea	11.7% 18/154 • Number of events 28 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	7.3% 12/164 • Number of events 16 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Gastrointestinal disorders Diarrhoea	6.5% 10/154 • Number of events 10 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	3.7% 6/164 • Number of events 6 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Gastrointestinal disorders Vomiting	3.9% 6/154 • Number of events 8 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	3.7% 6/164 • Number of events 9 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Gastrointestinal disorders Abdominal Pain	3.2% 5/154 • Number of events 6 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	2.4% 4/164 • Number of events 4 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Gastrointestinal disorders Abdominal Pain Upper	3.2% 5/154 • Number of events 5 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	1.2% 2/164 • Number of events 2 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Blood and lymphatic system disorders Anaemia	18.2% 28/154 • Number of events 33 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	23.2% 38/164 • Number of events 53 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Blood and lymphatic system disorders Neutropenia	6.5% 10/154 • Number of events 10 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	3.7% 6/164 • Number of events 12 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Blood and lymphatic system disorders Thrombocytopenia	5.2% 8/154 • Number of events 11 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	2.4% 4/164 • Number of events 6 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Blood and lymphatic system disorders Leukopenia	3.9% 6/154 • Number of events 6 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	2.4% 4/164 • Number of events 6 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.1% 14/154 • Number of events 16 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	6.1% 10/164 • Number of events 12 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Respiratory, thoracic and mediastinal disorders Cough	3.9% 6/154 • Number of events 7 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	4.9% 8/164 • Number of events 8 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.3% 2/154 • Number of events 3 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	3.7% 6/164 • Number of events 6 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/154 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	3.0% 5/164 • Number of events 5 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Cardiac disorders Sinus Tachycardia	4.5% 7/154 • Number of events 7 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	7.9% 13/164 • Number of events 15 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Cardiac disorders Atrial Fibrillation	3.9% 6/154 • Number of events 7 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	3.0% 5/164 • Number of events 6 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Cardiac disorders Sinus Bradycardia	1.9% 3/154 • Number of events 3 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	2.4% 4/164 • Number of events 4 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Cardiac disorders Ventricular Extrasystoles	1.9% 3/154 • Number of events 3 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	2.4% 4/164 • Number of events 5 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Cardiac disorders Atrioventricular Block	1.3% 2/154 • Number of events 2 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	2.4% 4/164 • Number of events 5 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Skin and subcutaneous tissue disorders Alopecia	5.8% 9/154 • Number of events 10 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	1.2% 2/164 • Number of events 2 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Skin and subcutaneous tissue disorders Rash	2.6% 4/154 • Number of events 4 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	2.4% 4/164 • Number of events 5 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Nervous system disorders Dizziness	7.8% 12/154 • Number of events 12 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	3.0% 5/164 • Number of events 5 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Nervous system disorders Headache	5.8% 9/154 • Number of events 9 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	3.0% 5/164 • Number of events 6 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Investigations Blood Creatinine Increased	3.2% 5/154 • Number of events 6 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	2.4% 4/164 • Number of events 4 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Metabolism and nutrition disorders Hyponatraemia	3.9% 6/154 • Number of events 7 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	2.4% 4/164 • Number of events 5 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Metabolism and nutrition disorders Hypoalbuminaemia	3.2% 5/154 • Number of events 5 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Metabolism and nutrition disorders Decreased Appetite	2.6% 4/154 • Number of events 5 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	3.7% 6/164 • Number of events 6 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Metabolism and nutrition disorders Hyperglycaemia	2.6% 4/154 • Number of events 4 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.00% 0/164 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Metabolism and nutrition disorders Hyperkalaemia	0.65% 1/154 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	4.3% 7/164 • Number of events 14 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Infections and infestations Nasopharyngitis	3.2% 5/154 • Number of events 6 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Infections and infestations Corona Virus Infection	1.3% 2/154 • Number of events 2 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	2.4% 4/164 • Number of events 4 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Musculoskeletal and connective tissue disorders Arthralgia	2.6% 4/154 • Number of events 6 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Musculoskeletal and connective tissue disorders Back Pain	2.6% 4/154 • Number of events 4 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	0.61% 1/164 • Number of events 1 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Musculoskeletal and connective tissue disorders Pain in Extremity	1.3% 2/154 • Number of events 2 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	3.0% 5/164 • Number of events 6 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer	6.5% 10/154 • Number of events 10 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.	11.6% 19/164 • Number of events 20 • Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1. The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.

Additional Information

Florin Muraru

Helsinn Healthcare SA

Phone: +41 91985 21 21

Email: florin.muraru@helsinn.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor has the sole right to first publication of the study data, which would be a multi-center publication. Investigators may publish the Study Data they obtained if they follow the conditions provided in the protocol. These include, but are not limited to: the multi-center publication has occurred; the Sponsor is given 60 days to review the document and possibly 60 more days to obtain Intellectual Property protections; and all Confidential Information is deleted, as requested by Sponsor.
• Publication restrictions are in place

Restriction type: OTHER