Trial Outcomes & Findings for Evaluate Safety and Biological Activity of ATYR1940 in Participants With Limb Girdle Muscular Dystrophy 2B (LGMD2B) and Facioscapulohumeral Muscular Dystrophy (FSHD) (NCT NCT02579239)
NCT ID: NCT02579239
Last Updated: 2023-10-19
Results Overview
TEAEs were defined as adverse events (AEs) with an onset following administration of the first dose of study drug. An AE was defined as any untoward medical occurrence in a participant administered study drug and that does not necessarily have a causal relationship with the study drug. Worsening of a pre-existing medical condition should have been considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. An SAE was defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in 'Reported Adverse Events' Section.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Up to End of Study (up to Week 25)
Results posted on
2023-10-19
Participant Flow
Participant milestones
| Measure |
Group A - FSHD
Participants with FSHD received single dose of placebo intravenous (IV) infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 milligrams/kilograms (mg/kg) once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks.
|
Group B - LGMD2B and FSHD
Participants with LGMD2B and FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 and 3.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
14
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
4
|
14
|
|
Overall Study
COMPLETED
|
4
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate Safety and Biological Activity of ATYR1940 in Participants With Limb Girdle Muscular Dystrophy 2B (LGMD2B) and Facioscapulohumeral Muscular Dystrophy (FSHD)
Baseline characteristics by cohort
| Measure |
Group A - FSHD
n=4 Participants
Participants with FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks.
|
Group B - LGMD2B and FSHD
n=14 Participants
Participants with LGMD2B and FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 and 3.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
45.0 years
STANDARD_DEVIATION 4.97 • n=99 Participants
|
36.3 years
STANDARD_DEVIATION 11.15 • n=107 Participants
|
38.2 years
STANDARD_DEVIATION 10.65 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to End of Study (up to Week 25)Population: Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation.
TEAEs were defined as adverse events (AEs) with an onset following administration of the first dose of study drug. An AE was defined as any untoward medical occurrence in a participant administered study drug and that does not necessarily have a causal relationship with the study drug. Worsening of a pre-existing medical condition should have been considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. An SAE was defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Group A - FSHD
n=4 Participants
Participants with FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks.
|
Group B - LGMD2B and FSHD
n=14 Participants
Participants with LGMD2B and FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 and 3.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
4 Participants
|
14 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to End of Study (up to Week 25)Population: Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation.
ECG parameters that were evaluated included heart rate, PR, and QR and QT intervals. A clinically significant ECG abnormality was based upon the Investigator's discretion. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Group A - FSHD
n=4 Participants
Participants with FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks.
|
Group B - LGMD2B and FSHD
n=14 Participants
Participants with LGMD2B and FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 and 3.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks.
|
|---|---|---|
|
Number of Participants With a Clinically Significant Electrocardiogram (ECG) Abnormality Leading to a TEAE
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to End of Study (up to Week 25)Population: Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation.
Pulmonary evaluations included pulmonary function tests and pulse oximetry. Clinically significant changes were to be reported as adverse events. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Group A - FSHD
n=4 Participants
Participants with FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks.
|
Group B - LGMD2B and FSHD
n=14 Participants
Participants with LGMD2B and FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 and 3.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks.
|
|---|---|---|
|
Number of Participants With a Clinically Significant Pulmonary Function Event Resulting in a TEAE
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to End of Study (up to Week 25)Population: Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation.
Laboratory parameters included hematology (hematocrit, hemoglobin, red blood cell count, white blood cell count with differential \[neutrophils, lymphocytes, monocytes, eosinophils, basophils\], and platelet count); serum chemistries (blood urea nitrogen, creatinine, total bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, total protein, sodium, potassium, bicarbonate, calcium, chloride, magnesium, inorganic phosphate, creatine kinase, lactate dehydrogenase, erythrocyte sedimentation rate, C-reactive protein, troponin, myoglobin, insulin-like growth factor 1, and cholesterol \[(nonfasting\]); urinalysis (color, pH, specific gravity, protein, glucose, ketones, and blood). Clinically significant laboratory abnormalities were based upon Investigator's discretion. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Group A - FSHD
n=4 Participants
Participants with FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks.
|
Group B - LGMD2B and FSHD
n=14 Participants
Participants with LGMD2B and FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 and 3.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks.
|
|---|---|---|
|
Number of Participants With a Clinical Laboratory Abnormality Leading to an AE
|
0 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to End of Study (Up to Week 25)Population: Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation.
The vital sign parameters that were evaluated included heart rate, systolic and diastolic blood pressure, and respiration rate as well as temperature. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Group A - FSHD
n=4 Participants
Participants with FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks.
|
Group B - LGMD2B and FSHD
n=14 Participants
Participants with LGMD2B and FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 and 3.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks.
|
|---|---|---|
|
Number of Participants With Vital Sign Abnormality Resulting in a TEAE
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 14Population: Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Here, 'Overall Number of Participants Analyzed' (N) signifies number of participants evaluable for this outcome measure.
MMT (muscle strength) was graded on a scale from 0 (no contraction palpable) to 5 (normal strength). Decreased muscle strength was indicated by a decreased score.
Outcome measures
| Measure |
Group A - FSHD
n=4 Participants
Participants with FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks.
|
Group B - LGMD2B and FSHD
n=13 Participants
Participants with LGMD2B and FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 and 3.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Manual Muscle Testing (MMT) Score at Week 14
|
-7.1 percent change
Standard Deviation 13.38
|
4.3 percent change
Standard Deviation 6.42
|
Adverse Events
Group A - FSHD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group B - LGMD2B and FSHD
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A - FSHD
n=4 participants at risk
Participants with FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks.
|
Group B - LGMD2B and FSHD
n=14 participants at risk
Participants with LGMD2B and FSHD received single dose of placebo IV infusion followed by ATYR1940 IV infusion at doses of 0.3 up to 1.0 and 3.0 mg/kg once weekly for 8 weeks and then twice weekly for 4 weeks using intraparticipant dose escalation for up to 12 weeks.
|
|---|---|---|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
50.0%
7/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
14.3%
2/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
General disorders
Asthenia
|
25.0%
1/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
14.3%
2/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
14.3%
2/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
21.4%
3/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
14.3%
2/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
14.3%
2/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
28.6%
4/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
14.3%
2/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
14.3%
2/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
General disorders
Feeling hot
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
General disorders
Infusion site pain
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
General disorders
Infusion site urticaria
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Infections and infestations
Tonsillitis
|
25.0%
1/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
0.00%
0/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
25.0%
1/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
0.00%
0/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Investigations
Insulin-like growth factor increased
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Investigations
Red blood cell sedimentation rate increased
|
25.0%
1/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
0.00%
0/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
1/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
0.00%
0/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
14.3%
2/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Eye disorders
Cataract
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/4 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
7.1%
1/14 • Up to End of Study (up to Week 25)
Safety population included all participants who received at least 1 full or partial dose of ATYR1940 and had a post-infusion safety observation. Serious Adverse Event and Other Adverse Event data were prespecified to be collected by the participant's assigned arm, regardless of the participant's dose level.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institutions and investigators agreed that no submission for publication or public disclosure will be made until after publication of the multi-center trial results by the sponsor, except in the following conditions: * notification by sponsor that such multi-center trial submission is no longer planned; * after the eighteen (18) month anniversary of the completion, abandonment or termination of such multi-center trial.
- Publication restrictions are in place
Restriction type: OTHER