Trial Outcomes & Findings for Safety and Dose-escalation Study of AAV2-hCHM in Participants With CHM (Choroideremia) Gene Mutations (NCT NCT02341807)
NCT ID: NCT02341807
Last Updated: 2024-01-25
Results Overview
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were AEs that occurred on or after the day of study drug administration. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2024-01-25
Participant Flow
Participant milestones
| Measure |
Cohort 1: AAV2-hCHM Dose 1
Single, unilateral subretinal administration of a single low dose range (up to 5x10\^10 vg/eye) of AAV2-hCHM (adeno-associated virus vector, serotype 2, containing the normal human choroideremia gene \[CHM\]).
|
Cohort 2: AAV2-hCHM Dose 2
Single, unilateral subretinal administration of a single high dose range (up to 1x10\^11 vg/eye) of AAV2-hCHM.
|
Cohort 3 (Expansion Cohort): AAV2-hCHM Dose 2
Single, unilateral subretinal administration of a single high dose range (up to 1x10\^11 vg/eye) of AAV2-hCHM.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Dose-escalation Study of AAV2-hCHM in Participants With CHM (Choroideremia) Gene Mutations
Baseline characteristics by cohort
| Measure |
Cohort 1: AAV2-hCHM Dose 1
n=5 Participants
Single, unilateral subretinal administration of a single low dose range of AAV2-hCHM.
|
Cohort 2: AAV2-hCHM Dose 2
n=5 Participants
Single, unilateral subretinal administration of a single high dose range of AAV2-hCHM.
|
Cohort 3 (Expansion Cohort): AAV2-hCHM Dose 2
n=5 Participants
Single, unilateral subretinal administration of a single high dose range of AAV2-hCHM.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.0 years
STANDARD_DEVIATION 7.52 • n=99 Participants
|
39.6 years
STANDARD_DEVIATION 11.65 • n=107 Participants
|
27.0 years
STANDARD_DEVIATION 5.00 • n=206 Participants
|
34.5 years
STANDARD_DEVIATION 9.68 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: FAS included all participants who received the investigational product.
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were AEs that occurred on or after the day of study drug administration. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Cohort 1: AAV2-hCHM Dose 1
n=5 Participants
Single, unilateral subretinal administration of a single low dose range of AAV2-hCHM.
|
Cohort 2: AAV2-hCHM Dose 2
n=5 Participants
Single, unilateral subretinal administration of a single high dose range of AAV2-hCHM.
|
Cohort 3 (Expansion Cohort): AAV2-hCHM Dose 2
n=5 Participants
Single, unilateral subretinal administration of a single high dose range of AAV2-hCHM.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
5 Participants
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: FAS included all participants who received the investigational product.
Number of participants who were found to have quantifiable levels (above 1.55 micrograms \[μg\]/milliliter \[mL\]) of Anti-AAV2 viral capsid antibodies titer in the blood at least 1 study visit up to 2 years were reported.
Outcome measures
| Measure |
Cohort 1: AAV2-hCHM Dose 1
n=5 Participants
Single, unilateral subretinal administration of a single low dose range of AAV2-hCHM.
|
Cohort 2: AAV2-hCHM Dose 2
n=5 Participants
Single, unilateral subretinal administration of a single high dose range of AAV2-hCHM.
|
Cohort 3 (Expansion Cohort): AAV2-hCHM Dose 2
n=5 Participants
Single, unilateral subretinal administration of a single high dose range of AAV2-hCHM.
|
|---|---|---|---|
|
Number of Participants With Anti-AAV2 Viral Capsid Antibody Titers That Rose Above Baseline At Least Once After Dosing
|
0 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: FAS included all participants who received the investigational product.
Interferon gamma ELISpot assays were used to evaluate the cellular immune response to AAV2 antigen in collected peripheral blood mononuclear cell (PBMC) samples. Number of participants who demonstrated immune response to the AAV2 antigen were reported.
Outcome measures
| Measure |
Cohort 1: AAV2-hCHM Dose 1
n=5 Participants
Single, unilateral subretinal administration of a single low dose range of AAV2-hCHM.
|
Cohort 2: AAV2-hCHM Dose 2
n=5 Participants
Single, unilateral subretinal administration of a single high dose range of AAV2-hCHM.
|
Cohort 3 (Expansion Cohort): AAV2-hCHM Dose 2
n=5 Participants
Single, unilateral subretinal administration of a single high dose range of AAV2-hCHM.
|
|---|---|---|---|
|
Number of Participants With Cellular Immune Response to AAV2 Through Interferon Gamma Enzyme-linked Immunosorbent Spot (ELISpot) Assay
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: FAS included all participants who received the investigational product.
Interferon gamma ELISpot assays were used to evaluate the cellular immune response to REP-1 antigen in collected PBMC samples. Number of participants who demonstrated immune response to the REP-1 antigen were reported.
Outcome measures
| Measure |
Cohort 1: AAV2-hCHM Dose 1
n=5 Participants
Single, unilateral subretinal administration of a single low dose range of AAV2-hCHM.
|
Cohort 2: AAV2-hCHM Dose 2
n=5 Participants
Single, unilateral subretinal administration of a single high dose range of AAV2-hCHM.
|
Cohort 3 (Expansion Cohort): AAV2-hCHM Dose 2
n=5 Participants
Single, unilateral subretinal administration of a single high dose range of AAV2-hCHM.
|
|---|---|---|---|
|
Number of Participants With Cellular Immune Response to Rab Escore Protein-1 (REP-1) Through Interferon Gamma ELISPOT Assay
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1: AAV2-hCHM Dose 1
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2: AAV2-hCHM Dose 2
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 3 (Expansion Cohort): AAV2-hCHM Dose 2
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: AAV2-hCHM Dose 1
n=5 participants at risk
Single, unilateral subretinal administration of a single low dose range of AAV2-hCHM.
|
Cohort 2: AAV2-hCHM Dose 2
n=5 participants at risk
Single, unilateral subretinal administration of a single high dose range of AAV2-hCHM.
|
Cohort 3 (Expansion Cohort): AAV2-hCHM Dose 2
n=5 participants at risk
Single, unilateral subretinal administration of a single high dose range of AAV2-hCHM.
|
|---|---|---|---|
|
Eye disorders
Macular hole
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Injury, poisoning and procedural complications
Concussion
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extragonadal primary seminoma (pure)
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
Other adverse events
| Measure |
Cohort 1: AAV2-hCHM Dose 1
n=5 participants at risk
Single, unilateral subretinal administration of a single low dose range of AAV2-hCHM.
|
Cohort 2: AAV2-hCHM Dose 2
n=5 participants at risk
Single, unilateral subretinal administration of a single high dose range of AAV2-hCHM.
|
Cohort 3 (Expansion Cohort): AAV2-hCHM Dose 2
n=5 participants at risk
Single, unilateral subretinal administration of a single high dose range of AAV2-hCHM.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Cataract
|
40.0%
2/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
40.0%
2/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Chalazion
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
80.0%
4/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Corneal disorder
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Corneal epithelium defect
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Diplopia
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Dry eye
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Eye irritation
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Eye pain
|
60.0%
3/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Eye pruritus
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Macular cyst
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Ocular hyperaemia
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Optic nerve sheath haemorrhage
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Retinoschisis
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Vision blurred
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Visual field defect
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Visual impairment
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Gastrointestinal disorders
Abdominal hernia
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
General disorders
Chest pain
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
40.0%
2/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
40.0%
2/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Injury, poisoning and procedural complications
Dental restoration failure
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Injury, poisoning and procedural complications
Iliotibial band syndrome
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
40.0%
2/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Investigations
Aspartate aminotransferase increase
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Investigations
Blood calcium decreased
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Investigations
Blood glucose increased
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Investigations
Intraocular pressure increased
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Investigations
Lymphocyte percentage abnormal
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Investigations
Urobilinogen urine increased
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Nervous system disorders
Ophthalmic migraine
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
40.0%
2/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Dellen
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
0.00%
0/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
20.0%
1/5 • Up to 5 years
FAS included all participants who received the investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place