Trial Outcomes & Findings for Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Oral Bisphosphonate (MK-0822-076) (NCT NCT01803607)
NCT ID: NCT01803607
Last Updated: 2019-09-04
Results Overview
Dual-energy X-ray absorptiometry (DXA) was used to determine the change from baseline in femoral neck BMD at Month 12.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
135 participants
Primary outcome timeframe
Baseline and Month 12
Results posted on
2019-09-04
Participant Flow
Postmenopausal female participants ≥60 years of age with low bone mineral density (BMD) and who had been treated with an oral bisphosphonate for at least 3 years were recruited at 81 sites in the United States.
The Sponsor made a business decision to terminate the trial early due to poor enrollment; the decision was not related to any findings regarding the efficacy or safety profile of odanacatib.
Participant milestones
| Measure |
Odanacatib 50 mg
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
Placebo
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
67
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
68
|
67
|
Reasons for withdrawal
| Measure |
Odanacatib 50 mg
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
Placebo
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Protocol Violation
|
3
|
2
|
|
Overall Study
Study terminated by sponsor
|
54
|
56
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
Baseline Characteristics
Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Oral Bisphosphonate (MK-0822-076)
Baseline characteristics by cohort
| Measure |
Odanacatib 50 mg
n=68 Participants
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
Placebo
n=67 Participants
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.7 Years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
70.7 Years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
70.9 Years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: The Full Analysis set (FAS) includes all randomized participants who took at least one dose of study medication and had the relevant baseline and follow-up measurements.
Dual-energy X-ray absorptiometry (DXA) was used to determine the change from baseline in femoral neck BMD at Month 12.
Outcome measures
| Measure |
Odanacatib 50 mg
n=24 Participants
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
Placebo
n=20 Participants
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
|---|---|---|
|
Percent Change From Baseline to Month 12 in Femoral BMD
|
0.70 Percent Change from Baseline
Standard Error 1.00
|
-0.20 Percent Change from Baseline
Standard Error 1.17
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: The trial was terminated prematurely, thus this analysis was not conducted.
DXA was used to determine the within-group change from baseline in femoral neck BMD at Month 24.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Month 12Population: The FAS includes all randomized participants who took at least one dose of study medication and had the relevant baseline and follow-up measurements
DXA was used to determine the change from baseline in trochanter, total hip, and lumbar spine BMD at Month 12.
Outcome measures
| Measure |
Odanacatib 50 mg
n=24 Participants
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
Placebo
n=20 Participants
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
|---|---|---|
|
Percent Change From Baseline to Month 12 in Trochanter, Total Hip, and Lumbar Spine BMD
Trochanter
|
1.85 Percentage Change from Baseline
Standard Error 1.14
|
-1.66 Percentage Change from Baseline
Standard Error 1.13
|
|
Percent Change From Baseline to Month 12 in Trochanter, Total Hip, and Lumbar Spine BMD
Total Hip
|
-0.09 Percentage Change from Baseline
Standard Error 0.63
|
-1.67 Percentage Change from Baseline
Standard Error 0.51
|
|
Percent Change From Baseline to Month 12 in Trochanter, Total Hip, and Lumbar Spine BMD
Lumbar Spine
|
2.10 Percentage Change from Baseline
Standard Error 0.99
|
-1.52 Percentage Change from Baseline
Standard Error 0.86
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: The Per Protocol (PP) population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results.
s-CTx is a biochemical marker of bone resorption. At baseline and Month 12, s-CTx was measured and expressed in ng/mL and results are expressed as percentage change from baseline.
Outcome measures
| Measure |
Odanacatib 50 mg
n=18 Participants
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
Placebo
n=23 Participants
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
|---|---|---|
|
Change From Baseline in Serum C-telopeptides of Type 1 Collagen (s-CTx)
|
15.37 Percent Change from Baseline
Standard Error 20.24
|
44.10 Percent Change from Baseline
Standard Error 10.19
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results.
u-CTx is a biochemical marker of bone resorption. At baseline and Month 12, u-CTx was measured and expressed in ug/mL and results are expressed as percentage change from baseline.
Outcome measures
| Measure |
Odanacatib 50 mg
n=17 Participants
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
Placebo
n=20 Participants
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
|---|---|---|
|
Change From Baseline in Urine C-telopeptides of Type I Collagen (u-CTx)
|
-82.39 Percentage Change from Baseline
Standard Error 22.46
|
63.21 Percentage Change from Baseline
Standard Error 23.08
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results.
The u-NTx/Cr ratio is a biochemical marker of bone resorption. u-NTx/Cr was measured at baseline and Month 12 and expressed in nM:mM and results are expressed as percentage change from baseline.
Outcome measures
| Measure |
Odanacatib 50 mg
n=17 Participants
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
Placebo
n=22 Participants
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
|---|---|---|
|
Change From Baseline in Urine N-telopeptides of Type 1 Collagen Corrected for Creatinine (u-NTx/Cr)
|
-29.78 Percentage Change from Baseline
Standard Error 13.46
|
37.73 Percentage Change from Baseline
Standard Error 10.46
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results
s-BSAP is a biochemical marker of bone resorption. s-BSAP was measured and expressed in ng/mL at Baseline and Month 12, and results are shown as percentage change from baseline.
Outcome measures
| Measure |
Odanacatib 50 mg
n=18 Participants
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
Placebo
n=23 Participants
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
|---|---|---|
|
Change From Baseline in Serum Bone Specific Alkaline Phosphatase (s-BSAP)
|
22.32 Percentage Change from Baseline
Standard Error 7.91
|
17.19 Percentage Change from Baseline
Standard Error 4.09
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results
s-P1NP is a biochemical marker of bone resorption. s-P1NP was measured and expressed as ng/mL at Baseline and Month 12, and results are expressed as percentage change from baseline.
Outcome measures
| Measure |
Odanacatib 50 mg
n=18 Participants
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
Placebo
n=23 Participants
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
|---|---|---|
|
Change From Baseline in Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP)
|
53.65 Percentage Change from Baseline
Standard Error 16.91
|
56.15 Percentage Change from Baseline
Standard Error 8.80
|
Adverse Events
ODN 50 mg OW
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo OW
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ODN 50 mg OW
n=67 participants at risk
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
Placebo OW
n=68 participants at risk
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. One participant who was randomized to odanacatib 50 mg OW received placebo during the entire treatment period and was therefore included in the Placebo OW group for safety analyses.
|
|---|---|---|
|
Cardiac disorders
Sinus bradycardia
|
1.5%
1/67 • Number of events 1 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
0.00%
0/68 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/67 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
1.5%
1/68 • Number of events 1 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
|
Infections and infestations
Diverticulitis
|
1.5%
1/67 • Number of events 1 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
0.00%
0/68 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/67 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
1.5%
1/68 • Number of events 1 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.5%
1/67 • Number of events 1 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
0.00%
0/68 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.5%
1/67 • Number of events 1 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
0.00%
0/68 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
1.5%
1/67 • Number of events 1 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
0.00%
0/68 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/67 • Number of events 1 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
0.00%
0/68 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/67 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
1.5%
1/68 • Number of events 1 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.5%
1/67 • Number of events 1 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
0.00%
0/68 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/67 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
1.5%
1/68 • Number of events 1 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.5%
1/67 • Number of events 1 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
0.00%
0/68 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
|
Renal and urinary disorders
Urinary retention
|
1.5%
1/67 • Number of events 1 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
0.00%
0/68 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
Other adverse events
| Measure |
ODN 50 mg OW
n=67 participants at risk
Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
|
Placebo OW
n=68 participants at risk
Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. One participant who was randomized to odanacatib 50 mg OW received placebo during the entire treatment period and was therefore included in the Placebo OW group for safety analyses.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
5/67 • Number of events 5 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
5.9%
4/68 • Number of events 4 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
|
Infections and infestations
Urinary tract infection
|
9.0%
6/67 • Number of events 7 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
4.4%
3/68 • Number of events 5 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
6.0%
4/67 • Number of events 4 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
4.4%
3/68 • Number of events 4 • Up to 54 weeks
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER