Trial Outcomes & Findings for Alvelestat (MPH966) for the Treatment of ALpha-1 ANTitrypsin Deficiency (NCT NCT03679598)
NCT ID: NCT03679598
Last Updated: 2024-08-20
Results Overview
To evaluate the effect of alvelestat (MPH966) administered twice daily (bid) for 12 weeks on blood markers of within-individual % change in plasma desmosine/isodesmosine will be measured.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
baseline, week 12
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Alvelestat (MPH966)
Alvelestat (MPH966) 120mg (4 30mg tablets) twice daily by mouth for 12 weeks
Alvelestat (MPH966): Alvelestat was developed as treatment for lung diseases like Chronic Obstructive Pulmonary Disease. Alevelestat works by blocking certain proteins in the body that are responsible for inflammation and damage to the lungs that can lead to COPD symptoms.
|
Placebo
4 Placebo tablets twice daily by mouth for 12 weeks
Placebo: Placebo is a pill or tablet that does not contain any study drug.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
|
Overall Study
COMPLETED
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Alvelestat (MPH966)
Alvelestat (MPH966) 120mg (4 30mg tablets) twice daily by mouth for 12 weeks
Alvelestat (MPH966): Alvelestat was developed as treatment for lung diseases like Chronic Obstructive Pulmonary Disease. Alevelestat works by blocking certain proteins in the body that are responsible for inflammation and damage to the lungs that can lead to COPD symptoms.
|
Placebo
4 Placebo tablets twice daily by mouth for 12 weeks
Placebo: Placebo is a pill or tablet that does not contain any study drug.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Alvelestat (MPH966) for the Treatment of ALpha-1 ANTitrypsin Deficiency
Baseline characteristics by cohort
| Measure |
Alvelestat (MPH966)
n=30 Participants
Alvelestat (MPH966) 120mg (4 30mg tablets) twice daily by mouth for 12 weeks
Alvelestat (MPH966): Alvelestat was developed as treatment for lung diseases like Chronic Obstructive Pulmonary Disease. Alevelestat works by blocking certain proteins in the body that are responsible for inflammation and damage to the lungs that can lead to COPD symptoms.
|
Placebo
n=31 Participants
4 Placebo tablets twice daily by mouth for 12 weeks
Placebo: Placebo is a pill or tablet that does not contain any study drug.
|
Total
n=61 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
|
|
Alpha-1 antitrypsin Genotype
Pi*NN
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Alpha-1 antitrypsin Genotype
Pi*SZ
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Alpha-1 antitrypsin Genotype
Pi*ZZ
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, week 12To evaluate the effect of alvelestat (MPH966) administered twice daily (bid) for 12 weeks on blood markers of within-individual % change in plasma desmosine/isodesmosine will be measured.
Outcome measures
| Measure |
Alvelestat (MPH966)
n=29 Participants
Alvelestat (MPH966) 120mg (4 30mg tablets) twice daily by mouth for 12 weeks
Alvelestat (MPH966): Alvelestat was developed as treatment for lung diseases like Chronic Obstructive Pulmonary Disease. Alevelestat works by blocking certain proteins in the body that are responsible for inflammation and damage to the lungs that can lead to COPD symptoms.
|
Placebo
n=30 Participants
4 Placebo tablets twice daily by mouth for 12 weeks
Placebo: Placebo is a pill or tablet that does not contain any study drug.
|
|---|---|---|
|
Within-individual % Change in Plasma Desmosine/Isodesmosine
|
10.0619 % change
Standard Deviation 27.8489
|
8.5627 % change
Standard Deviation 29.2973
|
PRIMARY outcome
Timeframe: baseline, week 16To evaluate the safety and tolerability of alvelestat (MPH966) administered twice daily (bid) for 12 weeks treatment numbers and % of subjects who experience at least 1 treatment-emergent adverse event (TEAE) will be measured.
Outcome measures
| Measure |
Alvelestat (MPH966)
n=32 Participants
Alvelestat (MPH966) 120mg (4 30mg tablets) twice daily by mouth for 12 weeks
Alvelestat (MPH966): Alvelestat was developed as treatment for lung diseases like Chronic Obstructive Pulmonary Disease. Alevelestat works by blocking certain proteins in the body that are responsible for inflammation and damage to the lungs that can lead to COPD symptoms.
|
Placebo
n=31 Participants
4 Placebo tablets twice daily by mouth for 12 weeks
Placebo: Placebo is a pill or tablet that does not contain any study drug.
|
|---|---|---|
|
Numbers and % of Subjects Who Experience at Least 1 Treatment-emergent Adverse Event
|
25 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: baseline, week 12To evaluate the effect of Alvelestat (MPH966) on other blood pharmacodynamic markers of neutrophil activation and elastase activity including plasma desmosine/isodesmosine (change compared to placebo; within-individual change is the primary outcome), plasma Aa-Val-360, serum NE activity, plasma proteinase 3, plasma cathepsin B, plasma CRP, plasma IL-6, plasma IL-8, plasma IL-1b, plasma RANTES, plasma LTB4, plasma MMP9, plasma MMP12, plasma MPO, and plasma PGP.
Outcome measures
| Measure |
Alvelestat (MPH966)
n=29 Participants
Alvelestat (MPH966) 120mg (4 30mg tablets) twice daily by mouth for 12 weeks
Alvelestat (MPH966): Alvelestat was developed as treatment for lung diseases like Chronic Obstructive Pulmonary Disease. Alevelestat works by blocking certain proteins in the body that are responsible for inflammation and damage to the lungs that can lead to COPD symptoms.
|
Placebo
n=30 Participants
4 Placebo tablets twice daily by mouth for 12 weeks
Placebo: Placebo is a pill or tablet that does not contain any study drug.
|
|---|---|---|
|
Blood Pharmacodynamic Markers of Neutrophil Activation and Elastase Activity. Change From Baseline in the Following Outcomes at End of the Treatment Within Patient and Compared to Placebo
Plasma PGP
|
-0.6619 ng/ mL
Standard Deviation 3.8013
|
-0.0139 ng/ mL
Standard Deviation 0.5418
|
|
Blood Pharmacodynamic Markers of Neutrophil Activation and Elastase Activity. Change From Baseline in the Following Outcomes at End of the Treatment Within Patient and Compared to Placebo
Plasma desmosine/isodesmosine
|
0.0307 ng/ mL
Standard Deviation 0.1012
|
0.0047 ng/ mL
Standard Deviation 0.0817
|
|
Blood Pharmacodynamic Markers of Neutrophil Activation and Elastase Activity. Change From Baseline in the Following Outcomes at End of the Treatment Within Patient and Compared to Placebo
Plasma Aa-Val-360
|
-1.6279 ng/ mL
Standard Deviation 4.1028
|
-0.9937 ng/ mL
Standard Deviation 4.3209
|
|
Blood Pharmacodynamic Markers of Neutrophil Activation and Elastase Activity. Change From Baseline in the Following Outcomes at End of the Treatment Within Patient and Compared to Placebo
Serum NE
|
-16.7926 ng/ mL
Standard Deviation 41.1503
|
3.9660 ng/ mL
Standard Deviation 19.4462
|
|
Blood Pharmacodynamic Markers of Neutrophil Activation and Elastase Activity. Change From Baseline in the Following Outcomes at End of the Treatment Within Patient and Compared to Placebo
Plasma proteinase 3
|
1.9412 ng/ mL
Standard Deviation 59.2846
|
-10.6390 ng/ mL
Standard Deviation 38.6356
|
|
Blood Pharmacodynamic Markers of Neutrophil Activation and Elastase Activity. Change From Baseline in the Following Outcomes at End of the Treatment Within Patient and Compared to Placebo
Plasma cathepsin B
|
7.2882 ng/ mL
Standard Deviation 24.9583
|
-1.1086 ng/ mL
Standard Deviation 14.6929
|
|
Blood Pharmacodynamic Markers of Neutrophil Activation and Elastase Activity. Change From Baseline in the Following Outcomes at End of the Treatment Within Patient and Compared to Placebo
Plasma CRP
|
-0.0247 ng/ mL
Standard Deviation 1.1066
|
-0.1975 ng/ mL
Standard Deviation 1.6880
|
|
Blood Pharmacodynamic Markers of Neutrophil Activation and Elastase Activity. Change From Baseline in the Following Outcomes at End of the Treatment Within Patient and Compared to Placebo
Plasma IL-6
|
0.3417 ng/ mL
Standard Deviation 2.1615
|
-0.3730 ng/ mL
Standard Deviation 2.7773
|
|
Blood Pharmacodynamic Markers of Neutrophil Activation and Elastase Activity. Change From Baseline in the Following Outcomes at End of the Treatment Within Patient and Compared to Placebo
Plasma IL-8
|
-0.2955 ng/ mL
Standard Deviation 2.9877
|
0.2386 ng/ mL
Standard Deviation 0.8844
|
|
Blood Pharmacodynamic Markers of Neutrophil Activation and Elastase Activity. Change From Baseline in the Following Outcomes at End of the Treatment Within Patient and Compared to Placebo
Plasma IL-1b
|
0.0962 ng/ mL
Standard Deviation 0.3819
|
0.1137 ng/ mL
Standard Deviation 0.5218
|
|
Blood Pharmacodynamic Markers of Neutrophil Activation and Elastase Activity. Change From Baseline in the Following Outcomes at End of the Treatment Within Patient and Compared to Placebo
Plasma RANTES
|
0.0903 ng/ mL
Standard Deviation 3.9356
|
0.0652 ng/ mL
Standard Deviation 6.4001
|
|
Blood Pharmacodynamic Markers of Neutrophil Activation and Elastase Activity. Change From Baseline in the Following Outcomes at End of the Treatment Within Patient and Compared to Placebo
Plasma LTB4
|
-369.093 ng/ mL
Standard Deviation 11118.482
|
170.2617 ng/ mL
Standard Deviation 1380.099
|
|
Blood Pharmacodynamic Markers of Neutrophil Activation and Elastase Activity. Change From Baseline in the Following Outcomes at End of the Treatment Within Patient and Compared to Placebo
Plasma MMP9
|
-2.8218 ng/ mL
Standard Deviation 18.6240
|
2.6188 ng/ mL
Standard Deviation 8.7639
|
|
Blood Pharmacodynamic Markers of Neutrophil Activation and Elastase Activity. Change From Baseline in the Following Outcomes at End of the Treatment Within Patient and Compared to Placebo
Plasma MMP12
|
-1.0733 ng/ mL
Standard Deviation 8.0076
|
-0.0940 ng/ mL
Standard Deviation 1.6722
|
|
Blood Pharmacodynamic Markers of Neutrophil Activation and Elastase Activity. Change From Baseline in the Following Outcomes at End of the Treatment Within Patient and Compared to Placebo
Plasma MPO
|
-4516.01 ng/ mL
Standard Deviation 24994.15
|
3156.253 ng/ mL
Standard Deviation 13798.49
|
Adverse Events
Alvelestat (MPH966)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alvelestat (MPH966)
n=32 participants at risk
Alvelestat (MPH966) 120mg (4 30mg tablets) twice daily by mouth for 12 weeks
Alvelestat (MPH966): Alvelestat was developed as treatment for lung diseases like Chronic Obstructive Pulmonary Disease. Alevelestat works by blocking certain proteins in the body that are responsible for inflammation and damage to the lungs that can lead to COPD symptoms.
|
Placebo
n=31 participants at risk
4 Placebo tablets twice daily by mouth for 12 weeks
Placebo: Placebo is a pill or tablet that does not contain any study drug.
|
|---|---|---|
|
Nervous system disorders
Headache
|
37.5%
12/32 • Number of events 15 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
22.6%
7/31 • Number of events 7 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
|
Nervous system disorders
Migraine
|
6.2%
2/32 • Number of events 2 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
6.5%
2/31 • Number of events 3 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
|
Nervous system disorders
Restless legs syndrome
|
3.1%
1/32 • Number of events 2 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
0.00%
0/31 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
|
Nervous system disorders
Sinus headache
|
6.2%
2/32 • Number of events 2 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
0.00%
0/31 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
3.1%
1/32 • Number of events 1 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
22.6%
7/31 • Number of events 7 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.1%
1/32 • Number of events 2 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
6.5%
2/31 • Number of events 2 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/32 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
9.7%
3/31 • Number of events 3 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
|
Reproductive system and breast disorders
Vaginal infection
|
3.1%
1/32 • Number of events 2 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
0.00%
0/31 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
2/32 • Number of events 2 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
3.2%
1/31 • Number of events 1 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
|
General disorders
Fatigue
|
6.2%
2/32 • Number of events 2 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
16.1%
5/31 • Number of events 5 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
|
Infections and infestations
Sinusitis
|
6.2%
2/32 • Number of events 2 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
0.00%
0/31 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
|
Investigations
Blood creatine phosphokinase increased
|
6.2%
2/32 • Number of events 3 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
0.00%
0/31 • Baseline to week 16
Adverse events of special interest include liver function abnormalities, corrected QT interval/cardiac, infections, and neutropenia. Treatment-emergent AEs (TEAEs) are defined as any AE occurring on or after the first dose of study medication. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), and summarized by system organ class and preferred term.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place