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 NCT01182337)
NCT ID: NCT01182337
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
31 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.
|
Vehicle Control
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
9
|
|
Overall Study
COMPLETED
|
19
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
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.
|
Vehicle Control
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
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
n=22 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.
|
Vehicle Control
n=9 Participants
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.4 years
STANDARD_DEVIATION 11.78 • n=5 Participants
|
40.6 years
STANDARD_DEVIATION 15.63 • n=7 Participants
|
41.2 years
STANDARD_DEVIATION 12.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
22 participants
n=5 Participants
|
9 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Safety Population For the Neurological Assessment at 12 months, only 21 subjects from the rhGDF-5 group completed the assessment (out of 22 total subjects) and 5 subjects from the Control group completed the assessment (out of 9 subjects 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=21 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.
|
Vehicle Control
n=5 Participants
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
|
|---|---|---|
|
Neurological Assessment for Motor Function and Reflexes/Sensory
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-upPopulation: Safety Population
Number of patients with Treatment Emergent Adverse Events that were designated as Definitely Related to Study Drug.
Outcome measures
| Measure |
Intradiscal rhGDF-5 1.0mg
n=22 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.
|
Vehicle Control
n=9 Participants
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
|
|---|---|---|
|
Treatment Emergent Adverse Events- Relationship to Study Drug
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-upPopulation: Safety Population
Number of patients with Treatment Emergent Adverse Events that were designated as Possibly or Probably Related to Study Drug.
Outcome measures
| Measure |
Intradiscal rhGDF-5 1.0mg
n=22 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.
|
Vehicle Control
n=9 Participants
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
|
|---|---|---|
|
Treatment Emergent Adverse Events- Relationship to Study Drug
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 12 monthPopulation: 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=22 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.
|
Vehicle Control
n=9 Participants
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
|
|---|---|---|
|
Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.
|
-13.5 units on a scale
Standard Deviation 13.86
|
-10.4 units on a scale
Standard Deviation 8.98
|
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=22 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.
|
Vehicle Control
n=9 Participants
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
|
|---|---|---|
|
Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.
|
-2.49 units on a scale
Standard Deviation 2.211
|
-1.42 units on a scale
Standard Deviation 3.177
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: FAS Population Only 21 subjects from the rhGDF-5 group (out of 22 total subjects) completed the baseline PCS, SF-36.
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=21 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.
|
Vehicle Control
n=9 Participants
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
|
|---|---|---|
|
Change in Physical Component Summary of Quality of Life Measure Assessed by Short Form 36 at 12 Months From Baseline
|
2.52 units on a scale
Standard Deviation 7.354
|
3.24 units on a scale
Standard Deviation 9.879
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: FAS Population Only 21 subjects from the rhGDF-5 group (out of 22 subjects total) completed the MCS, SF-36.
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=21 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.
|
Vehicle Control
n=9 Participants
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
|
|---|---|---|
|
Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline.
|
4.03 units on a scale
Standard Deviation 14.050
|
4.34 units on a scale
Standard Deviation 10.727
|
Adverse Events
Intradiscal rhGDF-5
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
Vehicle Control
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intradiscal rhGDF-5
n=22 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.
|
Vehicle Control
n=9 participants at risk
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
9.1%
2/22 • 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%
0/9 • 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%
0/22 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
4.5%
1/22 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Injury, poisoning and procedural complications
Meniscus Lesion
|
4.5%
1/22 • 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%
0/9 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Injury, poisoning and procedural complications
Muscle Injury
|
4.5%
1/22 • 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%
0/9 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
4.5%
1/22 • 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%
0/9 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.00%
0/22 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • 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
Appendicitis
|
4.5%
1/22 • 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%
0/9 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
4.5%
1/22 • 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%
0/9 • 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
n=22 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.
|
Vehicle Control
n=9 participants at risk
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
36.4%
8/22 • Number of events 9 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
33.3%
3/9 • Number of events 4 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
18.2%
4/22 • Number of events 5 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
0.00%
0/9 • 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
|
13.6%
3/22 • Number of events 3 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • 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
Intervertebral Disc Protrusion
|
9.1%
2/22 • 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%
0/9 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
4.5%
1/22 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • 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
Gastritis
|
0.00%
0/22 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • 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%
0/22 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • 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
Headache
|
4.5%
1/22 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • 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
Dizziness
|
0.00%
0/22 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
4.5%
1/22 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/22 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/22 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/22 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/22 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Vascular disorders
Varicose Vein
|
0.00%
0/22 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.00%
0/22 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/22 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • 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
Neck Pain
|
4.5%
1/22 • Number of events 1 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • 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
Trigger Finger
|
0.00%
0/22 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
11.1%
1/9 • 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
Upper Respiratory Tract Infection
|
9.1%
2/22 • 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%
0/9 • Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
9.1%
2/22 • 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%
0/9 • 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 Pain
|
9.1%
2/22 • 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%
0/9 • 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