Trial Outcomes & Findings for The Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Female Participants With Interstitial Cystitis /Bladder Pain Syndrome (MK-7264-005) (NCT NCT01569438)
NCT ID: NCT01569438
Last Updated: 2020-08-17
Results Overview
The bladder pain severity was measured using 0-10 NPRS, with 0 representing 'no pain' and 10 representing 'the worst pain possible'. Participants were asked to select a number on the scale that best described the severity of bladder pain during past 24 hours over telephone using an interactive voice response system (IVRS) every evening at bedtime during the baseline assessment phase and treatment phase (up to 4 weeks). The primary analysis was conducted using a Mixed Model with Repeated Measures (MMRM) approach to calculate the Least Squares (LS) mean change from baseline in NPRS score and associated Standard Error (SE) at Week 4 for each treatment arm. Negative values indicate decrease in bladder pain severity.
TERMINATED
PHASE2
107 participants
Baseline and Week 4
2020-08-17
Participant Flow
Overall, 107 participants were randomized (55 in Gefapixant intervention group, and 52 in Placebo group).
Of 107 participants randomized to the study, 105 received at least one dose of study treatment (All Treated Population) and were evaluable for all safety analysis.
Participant milestones
| Measure |
Placebo
Female participants receive dose matched placebo tablets, twice daily (BID), orally, with food for 4 weeks.
|
Gefapixant
Female participants receive gefapixant, a total dose titrated from 50 mg to highest tolerated dose (maximum of 300 mg) twice daily (BID), orally over a period of 6 days with food depending on safety and tolerability, and then maintain that dose for the course of a 4-week treatment period. Participants were allowed to decrease the dose if tolerability issues occurred.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
55
|
|
Overall Study
Treated
|
51
|
54
|
|
Overall Study
Titration Set
|
38
|
36
|
|
Overall Study
COMPLETED
|
45
|
33
|
|
Overall Study
NOT COMPLETED
|
7
|
22
|
Reasons for withdrawal
| Measure |
Placebo
Female participants receive dose matched placebo tablets, twice daily (BID), orally, with food for 4 weeks.
|
Gefapixant
Female participants receive gefapixant, a total dose titrated from 50 mg to highest tolerated dose (maximum of 300 mg) twice daily (BID), orally over a period of 6 days with food depending on safety and tolerability, and then maintain that dose for the course of a 4-week treatment period. Participants were allowed to decrease the dose if tolerability issues occurred.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Adverse Event
|
2
|
15
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Decrease of GFR greater than 30 ml/min
|
1
|
0
|
|
Overall Study
Sponsor/Physician decision
|
1
|
1
|
|
Overall Study
Unable to adhere to study schedule
|
0
|
1
|
Baseline Characteristics
NPRS score was calculated only on randomized participants who received at least had one dose of study treatment.
Baseline characteristics by cohort
| Measure |
Gefapixant
n=55 Participants
Female participants receive gefapixant, a total dose titrated from 50 mg to highest tolerated dose (maximum of 300 mg) twice daily (BID), orally over a period of 6 days with food depending on safety and tolerability, and then maintain that dose for the course of a 4-week treatment period. Participants were allowed to decrease the dose if tolerability issues occurred.
|
Placebo
n=52 Participants
Female participants receive dose matched placebo tablets, twice daily (BID), orally, with food for 4 weeks.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=55 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=107 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=55 Participants
|
52 Participants
n=52 Participants
|
102 Participants
n=107 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=55 Participants
|
0 Participants
n=52 Participants
|
5 Participants
n=107 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=55 Participants
|
52 Participants
n=52 Participants
|
107 Participants
n=107 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=55 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=107 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=55 Participants
|
0 Participants
n=52 Participants
|
3 Participants
n=107 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=55 Participants
|
52 Participants
n=52 Participants
|
104 Participants
n=107 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=55 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=107 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=55 Participants
|
0 Participants
n=52 Participants
|
2 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=55 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=55 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=55 Participants
|
6 Participants
n=52 Participants
|
11 Participants
n=107 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=55 Participants
|
46 Participants
n=52 Participants
|
92 Participants
n=107 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=55 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=55 Participants
|
0 Participants
n=52 Participants
|
2 Participants
n=107 Participants
|
|
Region of Enrollment
United States
|
55 Participants
n=55 Participants
|
52 Participants
n=52 Participants
|
107 Participants
n=107 Participants
|
|
Numeric Pain Rating Scale (NPRS) Score
|
6.20 Score on a scale
STANDARD_DEVIATION 1.41 • n=54 Participants • NPRS score was calculated only on randomized participants who received at least had one dose of study treatment.
|
6.53 Score on a scale
STANDARD_DEVIATION 1.23 • n=51 Participants • NPRS score was calculated only on randomized participants who received at least had one dose of study treatment.
|
6.36 Score on a scale
STANDARD_DEVIATION 1.33 • n=105 Participants • NPRS score was calculated only on randomized participants who received at least had one dose of study treatment.
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: Titration Completers Population - defined as participants who received at least 1 dose of drug, had at least 1 post-baseline NPRS Score, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase
The bladder pain severity was measured using 0-10 NPRS, with 0 representing 'no pain' and 10 representing 'the worst pain possible'. Participants were asked to select a number on the scale that best described the severity of bladder pain during past 24 hours over telephone using an interactive voice response system (IVRS) every evening at bedtime during the baseline assessment phase and treatment phase (up to 4 weeks). The primary analysis was conducted using a Mixed Model with Repeated Measures (MMRM) approach to calculate the Least Squares (LS) mean change from baseline in NPRS score and associated Standard Error (SE) at Week 4 for each treatment arm. Negative values indicate decrease in bladder pain severity.
Outcome measures
| Measure |
Gefapixant
n=26 Participants
Female participants receive gefapixant, a total dose titrated from 50 mg to highest tolerated dose (maximum of 300 mg) twice daily (BID), orally over a period of 6 days with food depending on safety and tolerability, and then maintain that dose for the course of a 4-week treatment period. Participants were allowed to decrease the dose if tolerability issues occurred.
|
Placebo
n=35 Participants
Female participants receive dose matched placebo tablets, twice daily (BID), orally, with food for 4 weeks.
|
|---|---|---|
|
Change From Baseline in the Average Mean Numeric Pain Rating Scale (NPRS) Score at Week 4
|
-2.6 Score on a scale
Standard Error 0.34
|
-1.9 Score on a scale
Standard Error 0.31
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Titration Completers Population - defined as participants who received at least 1 dose of drug, had at least 1 post-baseline PBIC-SD Score, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase.
To assess the severity of bladder pain syndrome (BPS), an 8-item participant self-report PBIC-SD measure was used. Participants were asked to select a number on the scale that best described the severity of bladder pain over telephone using an IVRS each evening on the three consecutive days (during the Baseline Assessment Phase and during each Treatment Week up to 4 weeks). Each item was graded on a scale from 0 (good condition) to 4 (poor condition) with a total score range 0-32. Higher scores indicate more severe BPS. The analysis was conducted using a MMRM approach to calculate the LS mean change from baseline PBIC-SD total score and associated SE at Week 4 for each treatment arm. Negative values indicate decrease in severity of BPS.
Outcome measures
| Measure |
Gefapixant
n=27 Participants
Female participants receive gefapixant, a total dose titrated from 50 mg to highest tolerated dose (maximum of 300 mg) twice daily (BID), orally over a period of 6 days with food depending on safety and tolerability, and then maintain that dose for the course of a 4-week treatment period. Participants were allowed to decrease the dose if tolerability issues occurred.
|
Placebo
n=36 Participants
Female participants receive dose matched placebo tablets, twice daily (BID), orally, with food for 4 weeks.
|
|---|---|---|
|
Change From Baseline in Painful Bladder/Interstitial Cystitis Symptom Diary (PBIC-SD) Score at Week 4
|
-7.8 Score on a scale
Standard Error 1.29
|
-6.7 Score on a scale
Standard Error 1.15
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Titration Completers Population - defined as participants who received at least 1 dose of drug, had at least 1 post-baseline ICSI Score, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase.
To measure the severity of BPS (urgency and frequency of urination, nighttime urination, and pain or burning) over past month, a 4-item self-report ICSI measure was used. Participants were asked to select a number on the scale that best described the severity of symptoms over telephone using an IVRS every evening at bedtime during the baseline assessment phase and treatment phase (up to 4 weeks). The ICSI score range from 0 (Not at all) to 5 (Almost always) for the first 3 items and a score of 0 (Not at all) to 4 (Almost always) for the last item, with an index score range of 0-19. Higher scores indicate more severe BPS. The analysis was conducted using one-way ANCOVA model to calculate the LS mean change from baseline ICSI total score and associated SE at Week 4 for each treatment arm. Negative values indicate decrease in severity of BPS.
Outcome measures
| Measure |
Gefapixant
n=35 Participants
Female participants receive gefapixant, a total dose titrated from 50 mg to highest tolerated dose (maximum of 300 mg) twice daily (BID), orally over a period of 6 days with food depending on safety and tolerability, and then maintain that dose for the course of a 4-week treatment period. Participants were allowed to decrease the dose if tolerability issues occurred.
|
Placebo
n=38 Participants
Female participants receive dose matched placebo tablets, twice daily (BID), orally, with food for 4 weeks.
|
|---|---|---|
|
Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 4
|
-3.8 Score on a scale
Standard Error 0.62
|
-3.4 Score on a scale
Standard Error 0.60
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Titration Completers Population - defined as participants who received at least 1 dose of drug, had at least 1 post-baseline GUPI Score, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase.
To measure the degree of genitourinary pain symptoms, an 8-item self-report GUPI measure was used. Participants were asked to select a number on the scale that best described the severity of symptoms over telephone using an IVRS every evening at bedtime during the baseline assessment phase and treatment phase (up to 4 weeks). The GUPI instrument yields a total score of 0-45 and 3 subscales: pain (score = 0-23), urinary (score = 0-10), and quality of life (score = 0-12). Higher scores indicate more severe symptoms. The analysis was conducted using one-way ANCOVA model to calculate the LS mean change from baseline GUPI total score and associated SE at Week 4 for each treatment arm. Negative values indicate decrease in degree of genitourinary pain symptoms.
Outcome measures
| Measure |
Gefapixant
n=34 Participants
Female participants receive gefapixant, a total dose titrated from 50 mg to highest tolerated dose (maximum of 300 mg) twice daily (BID), orally over a period of 6 days with food depending on safety and tolerability, and then maintain that dose for the course of a 4-week treatment period. Participants were allowed to decrease the dose if tolerability issues occurred.
|
Placebo
n=36 Participants
Female participants receive dose matched placebo tablets, twice daily (BID), orally, with food for 4 weeks.
|
|---|---|---|
|
Change From Baseline in Genitourinary Pain Index (GUPI) Score at Week 4
|
-5.1 Score on a scale
Standard Error 0.88
|
-3.7 Score on a scale
Standard Error 0.86
|
Adverse Events
Placebo
Gefapixant
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=51 participants at risk
Female participants receive dose matched placebo tablets, twice daily (BID), orally, with food for 4 weeks.
|
Gefapixant
n=54 participants at risk
Female participants receive gefapixant, a total dose titrated from 50 mg to highest tolerated dose (maximum of 300 mg) twice daily (BID), orally over a period of 6 days with food depending on safety and tolerability, and then maintain that dose for the course of a 4-week treatment period. Participants were allowed to decrease the dose if tolerability issues occurred.
|
|---|---|---|
|
Nervous system disorders
Dysgeusia
|
17.6%
9/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
70.4%
38/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
11.8%
6/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
9.3%
5/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
13.0%
7/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
5.6%
3/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
19.6%
10/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
18.5%
10/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
3.9%
2/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
13.0%
7/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
13.0%
7/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
11.1%
6/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
9.3%
5/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
5.9%
3/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
5.6%
3/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
5.6%
3/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
5.6%
3/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
5.9%
3/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
9.3%
5/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
2.0%
1/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
7.4%
4/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Bladder pain
|
5.9%
3/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
3.7%
2/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
13.0%
7/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
3.9%
2/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
5.6%
3/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
2.0%
1/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
5.6%
3/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Investigations
Urine output decreased
|
2.0%
1/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
13.0%
7/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
5.6%
3/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
13.0%
7/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
13.7%
7/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
3.7%
2/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
3/51 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
0.00%
0/54 • Up to approximately 6 weeks
All-Cause Mortality reported for all randomized participants. Serious Adverse Events (SAEs) and Other Adverse Events (AEs) were reported for all participants who received at least 1 dose of study treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee 60 days prior to the submission of any results, the PI shall submit to SPONSOR any proposed PUBLICATION, which period may be extended for an additional 30 days if requested by SPONSOR. If any Confidential Information should be redacted or patent applications relating to an Invention should be filed prior to PUBLICATION, then PUBLICATION will be delayed until patent application has been filed. Delay of a PUBLICATION shall not exceed 24 months from the date of such notice to the PI.
- Publication restrictions are in place
Restriction type: OTHER