Trial Outcomes & Findings for Diabetic Gastroparesis Study 05 (NCT NCT03786380)
NCT ID: NCT03786380
Last Updated: 2021-12-15
Results Overview
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
202 participants
Primary outcome timeframe
Up to approximately 22 months
Results posted on
2021-12-15
Participant Flow
Participants who completed relamorelin studies: RLM-MD-03 \[NCT03420781\] and RLM-MD-04 \[NCT03383146\] were eligible to enroll in this open-label safety study.
Participant milestones
| Measure |
Relamorelin/Relamorelin/Relamorelin
Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week randomized withdrawal period (RWP) of RLM-MD-03.
|
Relamorelin/Placebo/Relamorelin
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.
|
Placebo/Relamorelin/Relamorelin
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
|
Relamorelin/Relamorelin
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.
|
Placebo/Relamorelin
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
22
|
54
|
63
|
28
|
|
Overall Study
Safety Population
|
35
|
22
|
54
|
62
|
28
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
35
|
22
|
54
|
63
|
28
|
Reasons for withdrawal
| Measure |
Relamorelin/Relamorelin/Relamorelin
Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week randomized withdrawal period (RWP) of RLM-MD-03.
|
Relamorelin/Placebo/Relamorelin
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.
|
Placebo/Relamorelin/Relamorelin
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
|
Relamorelin/Relamorelin
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.
|
Placebo/Relamorelin
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
1
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Study Terminated by the Sponsor
|
30
|
20
|
50
|
57
|
23
|
|
Overall Study
Reason Not Specified
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Diabetic Gastroparesis Study 05
Baseline characteristics by cohort
| Measure |
Relamorelin/Relamorelin/Relamorelin
n=35 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
|
Relamorelin/Placebo/Relamorelin
n=22 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.
|
Placebo/Relamorelin/Relamorelin
n=54 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
|
Relamorelin/Relamorelin
n=63 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.
|
Placebo/Relamorelin
n=28 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 9.60 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 11.87 • n=7 Participants
|
55.7 years
STANDARD_DEVIATION 10.36 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 9.19 • n=4 Participants
|
58.5 years
STANDARD_DEVIATION 10.44 • n=21 Participants
|
58.1 years
STANDARD_DEVIATION 10.17 • n=10 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
146 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
56 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
70 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
132 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
37 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
160 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 22 monthsPopulation: Safety Population included all participants who received ≥1 administration of study treatment.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.
Outcome measures
| Measure |
Relamorelin/Relamorelin/Relamorelin
n=35 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
|
Relamorelin/Placebo/Relamorelin
n=22 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.
|
Placebo/Relamorelin/Relamorelin
n=54 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
|
Relamorelin/Relamorelin
n=62 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.
|
Placebo/Relamorelin
n=28 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
|
16 Participants
|
11 Participants
|
27 Participants
|
27 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to approximately 22 monthsPopulation: Safety Population included all participants who received ≥1 administration of study treatment. Number analyzed is the number of participants with non-PCS baseline values and at least one post-baseline assessment.
Clinical Laboratory tests included hematology, chemistry and urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Outcome measures
| Measure |
Relamorelin/Relamorelin/Relamorelin
n=35 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
|
Relamorelin/Placebo/Relamorelin
n=22 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.
|
Placebo/Relamorelin/Relamorelin
n=54 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
|
Relamorelin/Relamorelin
n=62 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.
|
Placebo/Relamorelin
n=28 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Potassium (mmol/L): <0.9×LLN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Eosinophils Absolute Cell Count [10^9/liter (L)]: >3×Upper Limit of Normal Value (ULN)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Hematocrit (RATIO): >1.1×ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN)
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Hemoglobin [grams (g)/L]: <0.9×LLN
|
2 Participants
|
5 Participants
|
11 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Lymphocytes Absolute Cell Count (10^9/L): >1.5×ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Mean Corpuscular Volume [femtoliter(fL)]: >1.1×ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Red Blood Cell Count (10^12/L): <0.9×LLN
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
White Blood Cell Count (10^9/L): <0.7×LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Alanine Aminotransferase [Serum Glutamic Pyruvic Transaminase (SGPT)] [unit(U)/L]: >=3×ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Aspartate Aminotransferase [Serum Glutamic Oxaloacetic Transaminase (SGOT)] (U/L): >=3×ULN
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Bicarbonate (HCO3) [millimoles (mmol)/L]: >1.1×ULN
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Bicarbonate (HCO3) (mmol/L): <0.9×LLN
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Blood Urea Nitrogen (mmol/L): >1.2×ULN
|
7 Participants
|
3 Participants
|
10 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Calcium (mmol/L): >1.1×ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Calcium (mmol/L): <0.9×LLN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Chloride (mmol/L): <0.9×LLN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Cholesterol, Total, Fasting (mmol/L): >1.6×ULN
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Creatinine [micromoles(μmol)/L]: >1.3×ULN
|
0 Participants
|
3 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN
|
5 Participants
|
2 Participants
|
12 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Glycohemoglobin A1C (%): Increase of >=0.5%
|
18 Participants
|
18 Participants
|
41 Participants
|
37 Participants
|
24 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Glycohemoglobin A1C (%): Increase of >=1%
|
18 Participants
|
18 Participants
|
41 Participants
|
36 Participants
|
24 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Phosphorus (mmol/L): >1.1×ULN
|
4 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Phosphorus (mmol/L): <0.9×LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Protein, Total (g/L): <0.9×LLN
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Triglycerides, Fasting (mmol/L): >=3×ULN
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Uric Acid (Urate) (μmol/L): >1.1×ULN
|
4 Participants
|
6 Participants
|
9 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Uric Acid (Urate) (μmol/L): <0.9×LLN
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 22 monthsPopulation: Safety Population included all participants who received ≥1 administration of study treatment.
Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.
Outcome measures
| Measure |
Relamorelin/Relamorelin/Relamorelin
n=35 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
|
Relamorelin/Placebo/Relamorelin
n=22 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.
|
Placebo/Relamorelin/Relamorelin
n=54 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
|
Relamorelin/Relamorelin
n=62 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.
|
Placebo/Relamorelin
n=28 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Meaningful Trends for Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 22 monthsPopulation: Safety Population included all participants who received ≥1 administration of study treatment.
A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Outcome measures
| Measure |
Relamorelin/Relamorelin/Relamorelin
n=35 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
|
Relamorelin/Placebo/Relamorelin
n=22 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.
|
Placebo/Relamorelin/Relamorelin
n=54 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
|
Relamorelin/Relamorelin
n=62 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.
|
Placebo/Relamorelin
n=28 Participants
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Relamorelin/Relamorelin/Relamorelin
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Relamorelin/Placebo/Relamorelin
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo/Relamorelin/Relamorelin
Serious events: 7 serious events
Other events: 15 other events
Deaths: 0 deaths
Relamorelin/Relamorelin
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo/Relamorelin
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Relamorelin/Relamorelin/Relamorelin
n=35 participants at risk
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
|
Relamorelin/Placebo/Relamorelin
n=22 participants at risk
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.
|
Placebo/Relamorelin/Relamorelin
n=54 participants at risk
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
|
Relamorelin/Relamorelin
n=62 participants at risk
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.
|
Placebo/Relamorelin
n=28 participants at risk
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
4.5%
1/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
3.7%
2/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.9%
1/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
4.5%
1/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.9%
1/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Cardiac disorders
Myocardial ischaemia
|
2.9%
1/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.6%
1/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.9%
1/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.9%
1/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.9%
1/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
4.5%
1/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
3.7%
2/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.9%
1/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Infections and infestations
Influenza
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
4.5%
1/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.9%
1/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.9%
1/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
4.5%
1/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
4.5%
1/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
2.9%
1/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
2.9%
1/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.9%
1/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.9%
1/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Nervous system disorders
Spinal claudication
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
4.5%
1/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Nervous system disorders
Syncope
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.6%
1/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Nervous system disorders
Thalamic infarction
|
2.9%
1/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.6%
1/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
4.5%
1/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.6%
1/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
4.5%
1/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
Other adverse events
| Measure |
Relamorelin/Relamorelin/Relamorelin
n=35 participants at risk
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
|
Relamorelin/Placebo/Relamorelin
n=22 participants at risk
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03.
|
Placebo/Relamorelin/Relamorelin
n=54 participants at risk
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03.
|
Relamorelin/Relamorelin
n=62 participants at risk
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks.
|
Placebo/Relamorelin
n=28 participants at risk
Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.6%
3/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
3.7%
2/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
8.1%
5/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
10.7%
3/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Infections and infestations
Urinary tract infection
|
5.7%
2/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
13.6%
3/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
3.7%
2/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
3.6%
1/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/26 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
7.1%
1/14 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/38 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/45 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
4.5%
1/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
2/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.9%
1/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.9%
1/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
9.1%
2/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
3.7%
2/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
3.2%
2/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.7%
2/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
2/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
3.7%
2/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
3.2%
2/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
7.1%
2/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
4.5%
1/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
5.6%
3/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
7.1%
2/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
|
Nervous system disorders
Headache
|
2.9%
1/35 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
0.00%
0/22 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
7.4%
4/54 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
1.6%
1/62 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
3.6%
1/28 • Up to approximately 22 months
All-Cause Mortality is reported for all randomized participants. The Safety Population, all participants who received ≥1 administration of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER