Trial Outcomes & Findings for ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®) (NCT NCT01218971)
NCT ID: NCT01218971
Last Updated: 2010-12-24
Results Overview
A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
332 participants
Primary outcome timeframe
Up to 48 weeks (13 injections), not including base study
Results posted on
2010-12-24
Participant Flow
Participant milestones
| Measure |
Medisorb Naltrexone 380 mg
|
Medisorb Naltrexone 190 mg
|
|---|---|---|
|
Overall Study
STARTED
|
175
|
157
|
|
Overall Study
COMPLETED
|
71
|
77
|
|
Overall Study
NOT COMPLETED
|
104
|
80
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)
Baseline characteristics by cohort
| Measure |
Medisorb Naltrexone 380 mg
n=175 Participants
|
Medisorb Naltrexone 190 mg
n=157 Participants
|
Total
n=332 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
168 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
317 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age Continuous
|
45.5 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
46.4 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
175 participants
n=5 Participants
|
157 participants
n=7 Participants
|
332 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeks (13 injections), not including base studyPopulation: All participants who received at least 1 dose of study drug are included in the safety population.
A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
Outcome measures
| Measure |
Medisorb Naltrexone 380 mg
n=175 Participants
|
Medisorb Naltrexone 190 mg
n=157 Participants
|
|---|---|---|
|
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study
|
143 Participants
|
130 Participants
|
Adverse Events
Medisorb Naltrexone 380mg--Combined
Serious events: 6 serious events
Other events: 143 other events
Deaths: 0 deaths
Medisorb Naltrexone 190mg--Combined
Serious events: 12 serious events
Other events: 130 other events
Deaths: 0 deaths
Placebo to 380mg
Serious events: 2 serious events
Other events: 51 other events
Deaths: 0 deaths
380mg to 380mg
Serious events: 4 serious events
Other events: 92 other events
Deaths: 0 deaths
Placebo to 190mg
Serious events: 2 serious events
Other events: 46 other events
Deaths: 0 deaths
190mg to 190mg
Serious events: 10 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Medisorb Naltrexone 380mg--Combined
n=175 participants at risk
Includes all participants who received Medisorb naltrexone 380mg in this extension study. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
|
Medisorb Naltrexone 190mg--Combined
n=157 participants at risk
Includes all participants who received Medisorb naltrexone 190mg in this extension study. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
|
Placebo to 380mg
n=60 participants at risk
Includes participants who received placebo in the base study but switched to Medisorb naltrexone 380mg in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
|
380mg to 380mg
n=115 participants at risk
Includes participants who received Medisorb naltrexone 380mg in the base study and continued with the same dose strength in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
|
Placebo to 190mg
n=55 participants at risk
Includes participants who received placebo in the base study but switched to Medisorb naltrexone 190mg in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
|
190mg to 190mg
n=102 participants at risk
includes participants who received Medisorb naltrexone 190mg in the base study and continued with the same dose strength in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration NOS
|
0.57%
1/175 • 1 year (Baseline to Week 52)
|
0.00%
0/157 • 1 year (Baseline to Week 52)
|
1.7%
1/60 • 1 year (Baseline to Week 52)
|
0.00%
0/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
0.00%
0/102 • 1 year (Baseline to Week 52)
|
|
Social circumstances
Drug abuser NOS
|
0.57%
1/175 • 1 year (Baseline to Week 52)
|
0.00%
0/157 • 1 year (Baseline to Week 52)
|
1.7%
1/60 • 1 year (Baseline to Week 52)
|
0.00%
0/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
0.00%
0/102 • 1 year (Baseline to Week 52)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/175 • 1 year (Baseline to Week 52)
|
0.64%
1/157 • 1 year (Baseline to Week 52)
|
0.00%
0/60 • 1 year (Baseline to Week 52)
|
0.00%
0/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
0.98%
1/102 • 1 year (Baseline to Week 52)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.57%
1/175 • 1 year (Baseline to Week 52)
|
0.00%
0/157 • 1 year (Baseline to Week 52)
|
0.00%
0/60 • 1 year (Baseline to Week 52)
|
0.87%
1/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
0.00%
0/102 • 1 year (Baseline to Week 52)
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
0.57%
1/175 • 1 year (Baseline to Week 52)
|
0.00%
0/157 • 1 year (Baseline to Week 52)
|
0.00%
0/60 • 1 year (Baseline to Week 52)
|
0.87%
1/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
0.00%
0/102 • 1 year (Baseline to Week 52)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.57%
1/175 • 1 year (Baseline to Week 52)
|
0.00%
0/157 • 1 year (Baseline to Week 52)
|
0.00%
0/60 • 1 year (Baseline to Week 52)
|
0.87%
1/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
0.00%
0/102 • 1 year (Baseline to Week 52)
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/175 • 1 year (Baseline to Week 52)
|
0.64%
1/157 • 1 year (Baseline to Week 52)
|
0.00%
0/60 • 1 year (Baseline to Week 52)
|
0.00%
0/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
0.98%
1/102 • 1 year (Baseline to Week 52)
|
|
General disorders
Chest pain
|
0.00%
0/175 • 1 year (Baseline to Week 52)
|
0.64%
1/157 • 1 year (Baseline to Week 52)
|
0.00%
0/60 • 1 year (Baseline to Week 52)
|
0.00%
0/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
0.98%
1/102 • 1 year (Baseline to Week 52)
|
|
Hepatobiliary disorders
Cholecystitis acute NOS
|
0.00%
0/175 • 1 year (Baseline to Week 52)
|
0.64%
1/157 • 1 year (Baseline to Week 52)
|
0.00%
0/60 • 1 year (Baseline to Week 52)
|
0.00%
0/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
0.98%
1/102 • 1 year (Baseline to Week 52)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/175 • 1 year (Baseline to Week 52)
|
0.64%
1/157 • 1 year (Baseline to Week 52)
|
0.00%
0/60 • 1 year (Baseline to Week 52)
|
0.00%
0/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
0.98%
1/102 • 1 year (Baseline to Week 52)
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/175 • 1 year (Baseline to Week 52)
|
0.64%
1/157 • 1 year (Baseline to Week 52)
|
0.00%
0/60 • 1 year (Baseline to Week 52)
|
0.00%
0/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
0.98%
1/102 • 1 year (Baseline to Week 52)
|
|
Infections and infestations
Pneumonia NOS
|
0.00%
0/175 • 1 year (Baseline to Week 52)
|
0.64%
1/157 • 1 year (Baseline to Week 52)
|
0.00%
0/60 • 1 year (Baseline to Week 52)
|
0.00%
0/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
0.98%
1/102 • 1 year (Baseline to Week 52)
|
|
Injury, poisoning and procedural complications
Limb injury NOS
|
0.00%
0/175 • 1 year (Baseline to Week 52)
|
0.64%
1/157 • 1 year (Baseline to Week 52)
|
0.00%
0/60 • 1 year (Baseline to Week 52)
|
0.00%
0/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
0.98%
1/102 • 1 year (Baseline to Week 52)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/175 • 1 year (Baseline to Week 52)
|
0.64%
1/157 • 1 year (Baseline to Week 52)
|
0.00%
0/60 • 1 year (Baseline to Week 52)
|
0.00%
0/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
0.98%
1/102 • 1 year (Baseline to Week 52)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/175 • 1 year (Baseline to Week 52)
|
0.64%
1/157 • 1 year (Baseline to Week 52)
|
0.00%
0/60 • 1 year (Baseline to Week 52)
|
0.00%
0/115 • 1 year (Baseline to Week 52)
|
1.8%
1/55 • 1 year (Baseline to Week 52)
|
0.00%
0/102 • 1 year (Baseline to Week 52)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma NOS
|
0.57%
1/175 • 1 year (Baseline to Week 52)
|
0.00%
0/157 • 1 year (Baseline to Week 52)
|
0.00%
0/60 • 1 year (Baseline to Week 52)
|
0.87%
1/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
0.00%
0/102 • 1 year (Baseline to Week 52)
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/175 • 1 year (Baseline to Week 52)
|
1.9%
3/157 • 1 year (Baseline to Week 52)
|
0.00%
0/60 • 1 year (Baseline to Week 52)
|
0.00%
0/115 • 1 year (Baseline to Week 52)
|
3.6%
2/55 • 1 year (Baseline to Week 52)
|
0.98%
1/102 • 1 year (Baseline to Week 52)
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/175 • 1 year (Baseline to Week 52)
|
0.64%
1/157 • 1 year (Baseline to Week 52)
|
0.00%
0/60 • 1 year (Baseline to Week 52)
|
0.00%
0/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
0.98%
1/102 • 1 year (Baseline to Week 52)
|
Other adverse events
| Measure |
Medisorb Naltrexone 380mg--Combined
n=175 participants at risk
Includes all participants who received Medisorb naltrexone 380mg in this extension study. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
|
Medisorb Naltrexone 190mg--Combined
n=157 participants at risk
Includes all participants who received Medisorb naltrexone 190mg in this extension study. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
|
Placebo to 380mg
n=60 participants at risk
Includes participants who received placebo in the base study but switched to Medisorb naltrexone 380mg in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
|
380mg to 380mg
n=115 participants at risk
Includes participants who received Medisorb naltrexone 380mg in the base study and continued with the same dose strength in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
|
Placebo to 190mg
n=55 participants at risk
Includes participants who received placebo in the base study but switched to Medisorb naltrexone 190mg in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
|
190mg to 190mg
n=102 participants at risk
includes participants who received Medisorb naltrexone 190mg in the base study and continued with the same dose strength in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
9.1%
16/175 • 1 year (Baseline to Week 52)
|
13.4%
21/157 • 1 year (Baseline to Week 52)
|
13.3%
8/60 • 1 year (Baseline to Week 52)
|
7.0%
8/115 • 1 year (Baseline to Week 52)
|
10.9%
6/55 • 1 year (Baseline to Week 52)
|
14.7%
15/102 • 1 year (Baseline to Week 52)
|
|
Infections and infestations
Upper respiratory tract infection NOS
|
10.3%
18/175 • 1 year (Baseline to Week 52)
|
11.5%
18/157 • 1 year (Baseline to Week 52)
|
10.0%
6/60 • 1 year (Baseline to Week 52)
|
10.4%
12/115 • 1 year (Baseline to Week 52)
|
12.7%
7/55 • 1 year (Baseline to Week 52)
|
10.8%
11/102 • 1 year (Baseline to Week 52)
|
|
Infections and infestations
Sinusitis NOS
|
4.0%
7/175 • 1 year (Baseline to Week 52)
|
5.7%
9/157 • 1 year (Baseline to Week 52)
|
8.3%
5/60 • 1 year (Baseline to Week 52)
|
1.7%
2/115 • 1 year (Baseline to Week 52)
|
7.3%
4/55 • 1 year (Baseline to Week 52)
|
4.9%
5/102 • 1 year (Baseline to Week 52)
|
|
Infections and infestations
Influenza
|
6.3%
11/175 • 1 year (Baseline to Week 52)
|
0.64%
1/157 • 1 year (Baseline to Week 52)
|
6.7%
4/60 • 1 year (Baseline to Week 52)
|
6.1%
7/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
0.98%
1/102 • 1 year (Baseline to Week 52)
|
|
Infections and infestations
Bronchitis NOS
|
3.4%
6/175 • 1 year (Baseline to Week 52)
|
1.9%
3/157 • 1 year (Baseline to Week 52)
|
5.0%
3/60 • 1 year (Baseline to Week 52)
|
2.6%
3/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
2.9%
3/102 • 1 year (Baseline to Week 52)
|
|
Infections and infestations
Gastroenteritis viral NOS
|
4.0%
7/175 • 1 year (Baseline to Week 52)
|
0.64%
1/157 • 1 year (Baseline to Week 52)
|
1.7%
1/60 • 1 year (Baseline to Week 52)
|
5.2%
6/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
0.98%
1/102 • 1 year (Baseline to Week 52)
|
|
General disorders
Injection site induration
|
6.3%
11/175 • 1 year (Baseline to Week 52)
|
3.2%
5/157 • 1 year (Baseline to Week 52)
|
15.0%
9/60 • 1 year (Baseline to Week 52)
|
1.7%
2/115 • 1 year (Baseline to Week 52)
|
7.3%
4/55 • 1 year (Baseline to Week 52)
|
0.98%
1/102 • 1 year (Baseline to Week 52)
|
|
General disorders
Fatigue
|
8.6%
15/175 • 1 year (Baseline to Week 52)
|
6.4%
10/157 • 1 year (Baseline to Week 52)
|
13.3%
8/60 • 1 year (Baseline to Week 52)
|
6.1%
7/115 • 1 year (Baseline to Week 52)
|
9.1%
5/55 • 1 year (Baseline to Week 52)
|
4.9%
5/102 • 1 year (Baseline to Week 52)
|
|
General disorders
Injection site pain
|
5.7%
10/175 • 1 year (Baseline to Week 52)
|
5.1%
8/157 • 1 year (Baseline to Week 52)
|
6.7%
4/60 • 1 year (Baseline to Week 52)
|
5.2%
6/115 • 1 year (Baseline to Week 52)
|
10.9%
6/55 • 1 year (Baseline to Week 52)
|
2.0%
2/102 • 1 year (Baseline to Week 52)
|
|
General disorders
Influenza like illness
|
1.7%
3/175 • 1 year (Baseline to Week 52)
|
7.6%
12/157 • 1 year (Baseline to Week 52)
|
3.3%
2/60 • 1 year (Baseline to Week 52)
|
0.87%
1/115 • 1 year (Baseline to Week 52)
|
7.3%
4/55 • 1 year (Baseline to Week 52)
|
7.8%
8/102 • 1 year (Baseline to Week 52)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
16/175 • 1 year (Baseline to Week 52)
|
5.7%
9/157 • 1 year (Baseline to Week 52)
|
10.0%
6/60 • 1 year (Baseline to Week 52)
|
8.7%
10/115 • 1 year (Baseline to Week 52)
|
9.1%
5/55 • 1 year (Baseline to Week 52)
|
3.9%
4/102 • 1 year (Baseline to Week 52)
|
|
Musculoskeletal and connective tissue disorders
Pain in limb
|
5.7%
10/175 • 1 year (Baseline to Week 52)
|
3.2%
5/157 • 1 year (Baseline to Week 52)
|
8.3%
5/60 • 1 year (Baseline to Week 52)
|
4.3%
5/115 • 1 year (Baseline to Week 52)
|
1.8%
1/55 • 1 year (Baseline to Week 52)
|
3.9%
4/102 • 1 year (Baseline to Week 52)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.3%
11/175 • 1 year (Baseline to Week 52)
|
5.7%
9/157 • 1 year (Baseline to Week 52)
|
3.3%
2/60 • 1 year (Baseline to Week 52)
|
7.8%
9/115 • 1 year (Baseline to Week 52)
|
3.6%
2/55 • 1 year (Baseline to Week 52)
|
6.9%
7/102 • 1 year (Baseline to Week 52)
|
|
Gastrointestinal disorders
Nausea
|
9.7%
17/175 • 1 year (Baseline to Week 52)
|
8.9%
14/157 • 1 year (Baseline to Week 52)
|
10.0%
6/60 • 1 year (Baseline to Week 52)
|
9.6%
11/115 • 1 year (Baseline to Week 52)
|
18.2%
10/55 • 1 year (Baseline to Week 52)
|
3.9%
4/102 • 1 year (Baseline to Week 52)
|
|
Gastrointestinal disorders
Vomiting NOS
|
2.9%
5/175 • 1 year (Baseline to Week 52)
|
5.1%
8/157 • 1 year (Baseline to Week 52)
|
5.0%
3/60 • 1 year (Baseline to Week 52)
|
1.7%
2/115 • 1 year (Baseline to Week 52)
|
1.8%
1/55 • 1 year (Baseline to Week 52)
|
6.9%
7/102 • 1 year (Baseline to Week 52)
|
|
Psychiatric disorders
Insomnia
|
6.3%
11/175 • 1 year (Baseline to Week 52)
|
7.0%
11/157 • 1 year (Baseline to Week 52)
|
6.7%
4/60 • 1 year (Baseline to Week 52)
|
6.1%
7/115 • 1 year (Baseline to Week 52)
|
7.3%
4/55 • 1 year (Baseline to Week 52)
|
6.9%
7/102 • 1 year (Baseline to Week 52)
|
|
Psychiatric disorders
Depression
|
2.9%
5/175 • 1 year (Baseline to Week 52)
|
9.6%
15/157 • 1 year (Baseline to Week 52)
|
5.0%
3/60 • 1 year (Baseline to Week 52)
|
1.7%
2/115 • 1 year (Baseline to Week 52)
|
14.5%
8/55 • 1 year (Baseline to Week 52)
|
6.9%
7/102 • 1 year (Baseline to Week 52)
|
|
Psychiatric disorders
Anxiety NEC
|
2.9%
5/175 • 1 year (Baseline to Week 52)
|
2.5%
4/157 • 1 year (Baseline to Week 52)
|
3.3%
2/60 • 1 year (Baseline to Week 52)
|
2.6%
3/115 • 1 year (Baseline to Week 52)
|
5.5%
3/55 • 1 year (Baseline to Week 52)
|
0.98%
1/102 • 1 year (Baseline to Week 52)
|
|
Psychiatric disorders
Alcoholism
|
1.1%
2/175 • 1 year (Baseline to Week 52)
|
3.2%
5/157 • 1 year (Baseline to Week 52)
|
0.00%
0/60 • 1 year (Baseline to Week 52)
|
1.7%
2/115 • 1 year (Baseline to Week 52)
|
7.3%
4/55 • 1 year (Baseline to Week 52)
|
0.98%
1/102 • 1 year (Baseline to Week 52)
|
|
Nervous system disorders
Headache NOS
|
10.3%
18/175 • 1 year (Baseline to Week 52)
|
12.7%
20/157 • 1 year (Baseline to Week 52)
|
13.3%
8/60 • 1 year (Baseline to Week 52)
|
8.7%
10/115 • 1 year (Baseline to Week 52)
|
7.3%
4/55 • 1 year (Baseline to Week 52)
|
15.7%
16/102 • 1 year (Baseline to Week 52)
|
|
Nervous system disorders
Dizziness
|
2.3%
4/175 • 1 year (Baseline to Week 52)
|
4.5%
7/157 • 1 year (Baseline to Week 52)
|
1.7%
1/60 • 1 year (Baseline to Week 52)
|
2.6%
3/115 • 1 year (Baseline to Week 52)
|
7.3%
4/55 • 1 year (Baseline to Week 52)
|
2.9%
3/102 • 1 year (Baseline to Week 52)
|
|
Injury, poisoning and procedural complications
Back injury NOS
|
0.57%
1/175 • 1 year (Baseline to Week 52)
|
1.9%
3/157 • 1 year (Baseline to Week 52)
|
0.00%
0/60 • 1 year (Baseline to Week 52)
|
0.87%
1/115 • 1 year (Baseline to Week 52)
|
5.5%
3/55 • 1 year (Baseline to Week 52)
|
0.00%
0/102 • 1 year (Baseline to Week 52)
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
2.3%
4/175 • 1 year (Baseline to Week 52)
|
2.5%
4/157 • 1 year (Baseline to Week 52)
|
5.0%
3/60 • 1 year (Baseline to Week 52)
|
0.87%
1/115 • 1 year (Baseline to Week 52)
|
1.8%
1/55 • 1 year (Baseline to Week 52)
|
2.9%
3/102 • 1 year (Baseline to Week 52)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.3%
4/175 • 1 year (Baseline to Week 52)
|
1.9%
3/157 • 1 year (Baseline to Week 52)
|
5.0%
3/60 • 1 year (Baseline to Week 52)
|
0.87%
1/115 • 1 year (Baseline to Week 52)
|
0.00%
0/55 • 1 year (Baseline to Week 52)
|
2.9%
3/102 • 1 year (Baseline to Week 52)
|
|
Metabolism and nutrition disorders
Appetite decreased NOS
|
2.3%
4/175 • 1 year (Baseline to Week 52)
|
2.5%
4/157 • 1 year (Baseline to Week 52)
|
3.3%
2/60 • 1 year (Baseline to Week 52)
|
1.7%
2/115 • 1 year (Baseline to Week 52)
|
7.3%
4/55 • 1 year (Baseline to Week 52)
|
0.00%
0/102 • 1 year (Baseline to Week 52)
|
|
Immune system disorders
Seasonal allergy
|
0.57%
1/175 • 1 year (Baseline to Week 52)
|
2.5%
4/157 • 1 year (Baseline to Week 52)
|
1.7%
1/60 • 1 year (Baseline to Week 52)
|
0.00%
0/115 • 1 year (Baseline to Week 52)
|
5.5%
3/55 • 1 year (Baseline to Week 52)
|
0.98%
1/102 • 1 year (Baseline to Week 52)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Should a PI wish to disclose results, the Sponsor will review the results communications prior to public release and can embargo results communications for a period of at least 30 days prior to the submission, for review and approval. Revisions will be negotiated in good faith by the Investigator and Sponsor and may be submitted for publication or disclosed by the Investigator only following receipt of written approval from the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER