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 NCT03743051)
NCT ID: NCT03743051
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 46 study sites in Bulgaria (4 sites), Hungary (5 sites), Italy (5 sites), Romania (6 sites), Russia (10 sites), Serbia (5 sites), and USA (11 sites). First Patient Enrollment (date of randomization) was on 05MAR2019.
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
|
159
|
159
|
|
Overall Study
Treated Patients
|
159
|
159
|
|
Overall Study
COMPLETED
|
78
|
76
|
|
Overall Study
NOT COMPLETED
|
81
|
83
|
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
|
5
|
9
|
|
Overall Study
Death
|
27
|
26
|
|
Overall Study
Lost to Follow-up
|
4
|
8
|
|
Overall Study
Withdrawal by Subject
|
32
|
19
|
|
Overall Study
Physician Decision
|
10
|
15
|
|
Overall Study
Reported as "Other" in Clinical Study Report
|
3
|
6
|
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=159 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=159 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
|
64.5 years
STANDARD_DEVIATION 9.20 • n=99 Participants
|
62.2 years
STANDARD_DEVIATION 10.55 • n=107 Participants
|
63.4 years
STANDARD_DEVIATION 9.95 • n=206 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=99 Participants
|
112 Participants
n=107 Participants
|
228 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
147 Participants
n=99 Participants
|
148 Participants
n=107 Participants
|
295 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
154 Participants
n=99 Participants
|
152 Participants
n=107 Participants
|
306 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Romania
|
16 participants
n=99 Participants
|
18 participants
n=107 Participants
|
34 participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
19 participants
n=99 Participants
|
23 participants
n=107 Participants
|
42 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
11 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Region of Enrollment
Serbia
|
23 participants
n=99 Participants
|
28 participants
n=107 Participants
|
51 participants
n=206 Participants
|
|
Region of Enrollment
Bulgaria
|
50 participants
n=99 Participants
|
43 participants
n=107 Participants
|
93 participants
n=206 Participants
|
|
Region of Enrollment
Russia
|
29 participants
n=99 Participants
|
27 participants
n=107 Participants
|
56 participants
n=206 Participants
|
|
Height
|
170.47 cm
STANDARD_DEVIATION 10.438 • n=99 Participants
|
172.09 cm
STANDARD_DEVIATION 9.910 • n=107 Participants
|
171.28 cm
STANDARD_DEVIATION 10.194 • n=206 Participants
|
|
Weight
|
53.71 kg
STANDARD_DEVIATION 8.049 • n=99 Participants
|
54.49 kg
STANDARD_DEVIATION 8.627 • n=107 Participants
|
54.10 kg
STANDARD_DEVIATION 8.339 • n=206 Participants
|
|
Body Mass Index
|
18.35 kg/m^2
STANDARD_DEVIATION 1.386 • n=99 Participants
|
18.24 kg/m^2
STANDARD_DEVIATION 1.578 • n=107 Participants
|
18.30 kg/m^2
STANDARD_DEVIATION 1.484 • n=206 Participants
|
|
Chemotherapy Line
First line
|
112 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
225 Participants
n=206 Participants
|
|
Chemotherapy Line
Second line
|
29 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Chemotherapy Line
Third line
|
18 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Anti-cancer Treatment
Immunotherapy
|
47 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Anti-cancer Treatment
Non-immunotherapy
|
112 Participants
n=99 Participants
|
111 Participants
n=107 Participants
|
223 Participants
n=206 Participants
|
|
5-IASS Score
≤10
|
108 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
217 Participants
n=206 Participants
|
|
5-IASS Score
>10
|
51 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
NSCLC stage at study entry
Stage IIIA
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
NSCLC stage at study entry
Stage IIIB
|
25 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
NSCLC stage at study entry
Stage IV
|
128 Participants
n=99 Participants
|
121 Participants
n=107 Participants
|
249 Participants
n=206 Participants
|
|
NSCLC stage at study entry
Missing
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Body weight change within 6 months prior to screening
|
-12.04 percent change
STANDARD_DEVIATION 7.160 • n=99 Participants
|
-11.05 percent change
STANDARD_DEVIATION 6.489 • n=107 Participants
|
-11.54 percent change
STANDARD_DEVIATION 6.840 • n=206 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=159 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=159 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
|
1.938 Change from baseline in body weight (kg)
Standard Error 0.285
|
0.594 Change from baseline in body weight (kg)
Standard Error 0.285
|
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=159 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=159 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
|
3.816 score on a scale
Standard Error 0.383
|
3.194 score on a scale
Standard Error 0.385
|
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=159 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=159 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 Body Weight (≥0 kg)
|
9.871 Weeks
Standard Error 0.476
|
7.462 Weeks
Standard Error 0.475
|
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=159 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=159 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 Body Weight (≥1.5 kg)
|
4.967 Weeks
Standard Error 0.434
|
3.631 Weeks
Standard Error 0.429
|
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=159 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=159 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)
|
10.523 Weeks
Standard Error 0.362
|
9.496 Weeks
Standard Error 0.359
|
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=159 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=159 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)
|
6.185 Weeks
Standard Error 0.423
|
5.650 Weeks
Standard Error 0.426
|
Adverse Events
100 mg Anamorelin HCl
Serious events: 43 serious events
Other events: 82 other events
Deaths: 27 deaths
Placebo
Serious events: 39 serious events
Other events: 87 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
100 mg Anamorelin HCl
n=159 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=159 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
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
9.4%
15/159 • 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.
|
10.1%
16/159 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.9%
3/159 • 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.
|
0.63%
1/159 • 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
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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)
Metastases to liver
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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
Pericardial effusion
|
1.3%
2/159 • 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%
0/159 • 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
Acute myocardial effusion
|
0.63%
1/159 • 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%
0/159 • 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 flutter
|
0.63%
1/159 • 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.
|
0.63%
1/159 • 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 arrest
|
0.63%
1/159 • 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%
0/159 • 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
|
0.63%
1/159 • 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%
0/159 • 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
Myocardial infarction
|
0.63%
1/159 • 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%
0/159 • 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
Acute coronary syndrome
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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
Atrial fibrillation
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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 tamponade
|
0.00%
0/159 • 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.
|
1.3%
2/159 • 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.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.63%
1/159 • 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%
0/159 • 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
Gastric haemorrhage
|
0.63%
1/159 • 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%
0/159 • 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
Ileus
|
0.63%
1/159 • 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%
0/159 • 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
Intestinal obstruction
|
0.63%
1/159 • 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%
0/159 • 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
Oesophageal stenosis
|
0.63%
1/159 • 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%
0/159 • 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
Small intestinal ulcer perforation
|
0.63%
1/159 • 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%
0/159 • 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
|
0.63%
1/159 • 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%
0/159 • 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
Diverticulum intestinal haemorrhagic
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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
Acute respiratory failure
|
1.3%
2/159 • 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%
0/159 • 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
|
1.3%
2/159 • 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%
0/159 • 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
|
1.3%
2/159 • 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%
0/159 • 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
|
0.63%
1/159 • 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.
|
0.63%
1/159 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.63%
1/159 • 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%
0/159 • 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
|
0.00%
0/159 • 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.
|
1.9%
3/159 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/159 • 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.
|
1.3%
2/159 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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
Bronchitis
|
1.3%
2/159 • 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%
0/159 • 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
Peritonitis
|
0.63%
1/159 • 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%
0/159 • 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
|
0.63%
1/159 • 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.
|
0.63%
1/159 • 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
|
0.63%
1/159 • 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.
|
0.63%
1/159 • 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
Viral infection
|
0.63%
1/159 • 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%
0/159 • 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
Empyema
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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
Gastroenteritis
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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
Pneumonia viral
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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
Respiratory tract infection
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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
|
0.63%
1/159 • 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.
|
0.63%
1/159 • 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
Depressed level of consciousness
|
0.63%
1/159 • 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%
0/159 • 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
Intracranial pressure increased
|
0.63%
1/159 • 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%
0/159 • 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%
0/159 • 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.
|
0.63%
1/159 • 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
Syncope
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.63%
1/159 • 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%
0/159 • 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
Pancytopenia
|
0.63%
1/159 • 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%
0/159 • 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
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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
Arthralgia
|
0.63%
1/159 • 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%
0/159 • 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
|
0.63%
1/159 • 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%
0/159 • 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
Osteonecrosis of jaw
|
0.63%
1/159 • 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%
0/159 • 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
Haematuria
|
0.63%
1/159 • 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%
0/159 • 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
Hydronephrosis
|
0.63%
1/159 • 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%
0/159 • 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
Urinary bladder haemorrhage
|
0.63%
1/159 • 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%
0/159 • 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%
0/159 • 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.
|
0.63%
1/159 • 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
Pain
|
0.63%
1/159 • 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%
0/159 • 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
Asthenia
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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
Oedema peripheral
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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
Sudden death
|
0.00%
0/159 • 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.
|
1.3%
2/159 • 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.
|
|
Injury, poisoning and procedural complications
Chemical peritonitis
|
0.63%
1/159 • 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%
0/159 • 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
Hepatic failure
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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
Alanine aminotransferase increased
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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
Aspartate aminotransferase increased
|
0.00%
0/159 • 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.
|
0.63%
1/159 • 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=159 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=159 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
|
5.0%
8/159 • 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.
|
2.5%
4/159 • 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.
|
|
General disorders
Fatigue
|
3.8%
6/159 • 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.
|
6.9%
11/159 • Number of events 13 • 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
|
3.8%
6/159 • 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.
|
3.8%
6/159 • 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.
|
|
General disorders
Chest Pain
|
1.3%
2/159 • 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.
|
4.4%
7/159 • 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.
|
|
General disorders
Pyrexia
|
1.3%
2/159 • 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.
|
2.5%
4/159 • 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.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.8%
14/159 • Number of events 17 • 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.
|
11.9%
19/159 • 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.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.5%
4/159 • 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.
|
0.63%
1/159 • 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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.3%
2/159 • 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.
|
2.5%
4/159 • 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
2/159 • 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.
|
3.1%
5/159 • 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.
|
|
Gastrointestinal disorders
Nausea
|
5.7%
9/159 • 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.
|
4.4%
7/159 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
4/159 • 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.
|
3.1%
5/159 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
3/159 • 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.
|
4.4%
7/159 • 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.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.8%
6/159 • 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.
|
1.3%
2/159 • 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.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
3.1%
5/159 • 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.
|
2.5%
4/159 • 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
Hypocalcaemia
|
3.1%
5/159 • 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.
|
0.63%
1/159 • 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
Platelet Count Decreased
|
2.5%
4/159 • 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.
|
2.5%
4/159 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
6/159 • 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.
|
4.4%
7/159 • 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
Cough
|
0.00%
0/159 • 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.
|
2.5%
4/159 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/159 • 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.
|
2.5%
4/159 • 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.
|
|
Nervous system disorders
Headache
|
2.5%
4/159 • 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.
|
1.9%
3/159 • 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.
|
|
Infections and infestations
Corona Virus Infection
|
0.00%
0/159 • 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.
|
2.5%
4/159 • 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.
|
Additional Information
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