Trial Outcomes & Findings for A Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration (NCT NCT01158924)
NCT ID: NCT01158924
Last Updated: 2016-02-26
Results Overview
Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months. For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance. For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
12 months
Results posted on
2016-02-26
Participant Flow
Participant milestones
| Measure |
Intradiscal rhGDF-5 (1.0mg)
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
Intradiscal rhGDF-5 (2.0mg)
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
26
|
|
Overall Study
COMPLETED
|
13
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Intradiscal rhGDF-5 (1.0mg)
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
Intradiscal rhGDF-5 (2.0mg)
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration
Baseline characteristics by cohort
| Measure |
Intradiscal rhGDF-5 (1.0mg)
n=14 Participants
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
Intradiscal rhGDF-5 (2.0mg)
n=26 Participants
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 10.85 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 10.37 • n=7 Participants
|
46.9 years
STANDARD_DEVIATION 10.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
14 participants
n=5 Participants
|
26 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Safety Population The Neurological Assessment at 12 months was only conducted on 13 subjects from the 1.0mg group (out of 14 total subjects) and 25 subjects from the 2.0 mg group (out of 26 total).
Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months. For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance. For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs.
Outcome measures
| Measure |
Intradiscal rhGDF-5 (1.0mg)
n=13 Participants
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
Intradiscal rhGDF-5 (2.0mg)
n=25 Participants
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
|---|---|---|
|
Neurological Assessment for Motor Function and Reflexes/Sensory
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up.Population: Safety Population
Number of patients with Treatment Emergent Adverse Events that were designated as related or possibly related to Study Drug.
Outcome measures
| Measure |
Intradiscal rhGDF-5 (1.0mg)
n=14 Participants
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
Intradiscal rhGDF-5 (2.0mg)
n=26 Participants
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
|---|---|---|
|
Treatment Emergent Adverse Events- Relationship to Study Drug
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: FAS Population
The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.
Outcome measures
| Measure |
Intradiscal rhGDF-5 (1.0mg)
n=14 Participants
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
Intradiscal rhGDF-5 (2.0mg)
n=26 Participants
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
|---|---|---|
|
Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline
|
-13.0 units on a scale
Standard Deviation 14.63
|
-18.1 units on a scale
Standard Deviation 13.69
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: FAS Population
The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.
Outcome measures
| Measure |
Intradiscal rhGDF-5 (1.0mg)
n=14 Participants
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
Intradiscal rhGDF-5 (2.0mg)
n=26 Participants
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
|---|---|---|
|
Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.
|
-2.66 units on a scale
Standard Deviation 3.448
|
-3.80 units on a scale
Standard Deviation 2.651
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: FAS Population
The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).
Outcome measures
| Measure |
Intradiscal rhGDF-5 (1.0mg)
n=14 Participants
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
Intradiscal rhGDF-5 (2.0mg)
n=26 Participants
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
|---|---|---|
|
Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.
|
11.18 units on a scale
Standard Deviation 13.206
|
10.00 units on a scale
Standard Deviation 9.897
|
Adverse Events
Intradiscal rhGDF-5 (1.0mg)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Intradiscal rhGDF-5 (2.0mg)
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intradiscal rhGDF-5 (1.0mg)
n=14 participants at risk
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
Intradiscal rhGDF-5 (2.0mg)
n=26 participants at risk
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/14 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
3.8%
1/26 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/14 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
3.8%
1/26 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Nervous system disorders
Guillain-Barre Syndrome
|
0.00%
0/14 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
3.8%
1/26 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Nervous system disorders
Migraine
|
0.00%
0/14 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
3.8%
1/26 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/14 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
3.8%
1/26 • Number of events 2 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Cardiac disorders
Angina Pectoris
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
Other adverse events
| Measure |
Intradiscal rhGDF-5 (1.0mg)
n=14 participants at risk
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
Intradiscal rhGDF-5 (2.0mg)
n=26 participants at risk
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
21.4%
3/14 • Number of events 7 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
46.2%
12/26 • Number of events 20 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/14 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
7.7%
2/26 • Number of events 2 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Infections and infestations
Influenza
|
0.00%
0/14 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
7.7%
2/26 • Number of events 2 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
3.8%
1/26 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
7.7%
2/26 • Number of events 2 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Infections and infestations
Gastroenteritis
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Infections and infestations
Pneumonia
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Infections and infestations
Rhinitis
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Infections and infestations
Staphlococcal Infection
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
4/14 • Number of events 4 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
3.8%
1/26 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
7.7%
2/26 • Number of events 2 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
7.7%
2/26 • Number of events 2 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
2/14 • Number of events 3 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
7.7%
2/26 • Number of events 2 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
21.4%
3/14 • Number of events 4 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Nervous system disorders
Migraine
|
21.4%
3/14 • Number of events 5 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
3.8%
1/26 • Number of events 2 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Nervous system disorders
Ataxia
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Nervous system disorders
Paraesthesia
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Nervous system disorders
Parosmia
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Nervous system disorders
Peripheral Sensorimotor Neuropathy
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Nervous system disorders
Sciatica
|
7.1%
1/14 • Number of events 2 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.1%
1/14 • Number of events 3 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Skin and subcutaneous tissue disorders
Subcutaneous Nodule
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/14 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
7.7%
2/26 • Number of events 2 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
3.8%
1/26 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Spasm
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Immune system disorders
Seasonal Allergy
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Cardiac disorders
Angina Pectoris
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Investigations
Hepatic Enzyme Increased
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/26 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Investigators may freely present or publish results of the Clinical Investigation in a manner which fairly sets forth the conclusions reached by the Clinical Investigators, but only after the Sponsor has been given the opportunity of reviewing the proposed presentation or publication at least 60 days prior to the intended submission, presentation, or publication date.
- Publication restrictions are in place
Restriction type: OTHER