Trial Outcomes & Findings for Trial Investigating the Efficacy and Safety of SCH 900435 (Org 25935) in Relapse Prevention in Participants With Alcohol Dependence (P05718) (NCT NCT00764660)
NCT ID: NCT00764660
Last Updated: 2018-10-16
Results Overview
Percentage of heavy drinking days was defined as days with ≥5 standard drinks for men and ≥4 standard drinks for women assessed by Alcohol Timeline Follow Back (TLFB) method. The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking by means of an interview between investigator and participant. The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period prior to the interview, and thus the measure provides quantitative estimates of alcohol use. A drink is standardized to an equivalent to 25-30 cL of beer or wine coolers (5% alcohol), 12-15 cL of table wine (11-14% alcohol) and 4-6 cL of hard liquor/spirits (35-40% alcohol). Percentage was calculated based on number of heavy drinking days divided by total number of days in the given 2-week interval.
TERMINATED
PHASE2
141 participants
12 weeks
2018-10-16
Participant Flow
Participant milestones
| Measure |
SCH 900435 12 mg
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
66
|
|
Overall Study
COMPLETED
|
53
|
55
|
|
Overall Study
NOT COMPLETED
|
22
|
11
|
Reasons for withdrawal
| Measure |
SCH 900435 12 mg
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
7
|
3
|
|
Overall Study
Noncompliance With Protocol
|
5
|
1
|
|
Overall Study
Did Not Meet Protocol Eligibility
|
1
|
0
|
Baseline Characteristics
Trial Investigating the Efficacy and Safety of SCH 900435 (Org 25935) in Relapse Prevention in Participants With Alcohol Dependence (P05718)
Baseline characteristics by cohort
| Measure |
SCH 900435 12 mg
n=75 Participants
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
n=66 Participants
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.5 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
50.3 Years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
49.3 Years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The modified Intent-to-Treat (mITT) population consisted of all participants from the All-Participants-Treated (APT) population who had at least post randomization efficacy data for this outcome measure.
Percentage of heavy drinking days was defined as days with ≥5 standard drinks for men and ≥4 standard drinks for women assessed by Alcohol Timeline Follow Back (TLFB) method. The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking by means of an interview between investigator and participant. The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period prior to the interview, and thus the measure provides quantitative estimates of alcohol use. A drink is standardized to an equivalent to 25-30 cL of beer or wine coolers (5% alcohol), 12-15 cL of table wine (11-14% alcohol) and 4-6 cL of hard liquor/spirits (35-40% alcohol). Percentage was calculated based on number of heavy drinking days divided by total number of days in the given 2-week interval.
Outcome measures
| Measure |
SCH 900435 12 mg
n=74 Participants
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
n=65 Participants
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
|---|---|---|
|
Percentage of Heavy Drinking Days
|
18.7 Percentage of Days
Interval 14.5 to 23.0
|
16.3 Percentage of Days
Interval 11.8 to 20.8
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.
The amount of drinking was defined as drinks per drinking day (TLFB). Drinking day is a day on which an alcoholic drink is consumed, with 'day' being defined as the period between waking up and going to sleep; the end of a day may have crossed the time point of midnight.
Outcome measures
| Measure |
SCH 900435 12 mg
n=49 Participants
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
n=47 Participants
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
|---|---|---|
|
Number of Drinks Per Drinking Day
|
10.9 Drinks
Interval 8.2 to 13.5
|
12.8 Drinks
Interval 9.9 to 15.6
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.
An alcohol relapse was defined as either a daily alcohol intake of 5 or more drinks for males and 4 or more drinks for females or an overall consumption of 14 drinks or more per week during at least 4 weeks (TLFB).
Outcome measures
| Measure |
SCH 900435 12 mg
n=74 Participants
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
n=65 Participants
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
|---|---|---|
|
Number of Relapses Into Heavy Drinking
|
4.65 Relapses
Standard Deviation 6.24
|
4.52 Relapses
Standard Deviation 5.27
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.
An alcohol lapse was defined as any episode of alcohol consumption not classified as a relapse (TLFB).
Outcome measures
| Measure |
SCH 900435 12 mg
n=74 Participants
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
n=65 Participants
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
|---|---|---|
|
Number of Lapses Into Any Drinking
|
5.59 Lapses
Standard Deviation 6.33 • Interval 0.31 to 4.86
|
6.37 Lapses
Standard Deviation 6.49 • Interval 0.24 to 4.73
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.
Time to relapse was defined as the time to first relapse into heavy drinking (TLFB). A Hazard Ratio (SCH 900435/Placebo) of \<1 means that SCH 900435 has a lower risk of relapsing as compared to Placebo.
Outcome measures
| Measure |
SCH 900435 12 mg
n=74 Participants
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
n=65 Participants
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
|---|---|---|
|
Time to First Relapse Into Drinking
|
37.1 Days
Standard Deviation 35.5
|
41.6 Days
Standard Deviation 36.3
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.
Percentage of abstinent days is the percentage of study days in which participants remained abstinent during the treatment period.
Outcome measures
| Measure |
SCH 900435 12 mg
n=74 Participants
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
n=65 Participants
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
|---|---|---|
|
Percentage of Abstinent Days
|
70.5 Percentage of Days
Interval 64.9 to 76.2
|
72.6 Percentage of Days
Interval 66.6 to 78.6
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.
Percentage of total abstinence is the percentage of participants who remained abstinent during the entire treatment period.
Outcome measures
| Measure |
SCH 900435 12 mg
n=74 Participants
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
n=65 Participants
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Complete Abstinence
|
33.8 Percentage of Participants
Interval 64.9 to 76.2
|
27.7 Percentage of Participants
Interval 66.6 to 78.6
|
SECONDARY outcome
Timeframe: Day 84Population: The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.
The CGI scale is a standardized tool used by investigators to rate the severity of illness, taking into account the participant's clinical condition and the severity of side effects. The CGI scores could range from 1 to 7, with a lower score reflecting a better outcome.
Outcome measures
| Measure |
SCH 900435 12 mg
n=34 Participants
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
n=38 Participants
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
|---|---|---|
|
Global Functioning: Clinical Global Impression (CGI) - Severity of Illness
|
2.7 Score on a Scale
Standard Deviation 1.3
|
2.7 Score on a Scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Day 84Population: The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.
The CGI scale is a standardized tool used by investigators to rate the efficacy of study drug (therapeutic effect), taking into account the participant's clinical condition and the severity of side effects. The CGI scores could range from 1 to 7, with a lower score reflecting a better outcome.
Outcome measures
| Measure |
SCH 900435 12 mg
n=34 Participants
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
n=38 Participants
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
|---|---|---|
|
Global Functioning: CGI - Therapeutic Effect
|
2.1 Score on a Scale
Standard Deviation 1.2
|
2.0 Score on a Scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline and Day 84Population: The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.
Rating of craving is included to assess a potential relationship between treatment and craving severity. Participants were asked to answer the question: "Over the past week, what has your desire or craving for an alcoholic beverage been at the time of day that you usually drink?" The 100 mm line of the VAS was anchored on the left by "No desire at all" and on the right by "Extreme desire". Participants marked a spot on the line where they felt their craving severity fit best. Craving VAS scores could range from 0 to 100, with a lower VAS score reflecting a better outcome.
Outcome measures
| Measure |
SCH 900435 12 mg
n=36 Participants
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
n=39 Participants
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Craving Visual Analog Scale (VAS) Score
|
-3.56 Score on a Scale
Interval -10.53 to 3.41
|
-6.44 Score on a Scale
Interval -13.25 to 0.38
|
SECONDARY outcome
Timeframe: Baseline and Day 84Population: The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.
Participants were asked to answer the question: "Over the past week, how motivated were you to stay alcohol abstinent?" The 100 mm line of the VAS was anchored on the left by "No motivation at all" and on the right by "Extremely motivated". Motivation VAS scores could range from 0 to 100, with a higher score reflecting a better outcome.
Outcome measures
| Measure |
SCH 900435 12 mg
n=36 Participants
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
n=39 Participants
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Motivation VAS Score
|
-8.09 Score on a Scale
Interval -14.85 to -1.33
|
-4.99 Score on a Scale
Interval -11.66 to 1.68
|
SECONDARY outcome
Timeframe: Baseline and Day 84Population: The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.
Participants were asked to answer the question: "Over the past week, how did you feel?" The 100 mm line of the VAS was anchored on the left by "Extremely bad" and on the right by "Extremely good". Mood VAS scores could range from 0 to 100, with a higher VAS score reflecting a better outcome.
Outcome measures
| Measure |
SCH 900435 12 mg
n=36 Participants
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
n=39 Participants
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Mood VAS Score
|
-5.29 Score on a Scale
Interval -12.01 to 1.42
|
3.88 Score on a Scale
Interval -2.74 to 10.49
|
SECONDARY outcome
Timeframe: Up to 16 weeksPopulation: The All-Participants-Treated (APT) population consisted of all participants who received at least one dose of study drug.
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.
Outcome measures
| Measure |
SCH 900435 12 mg
n=75 Participants
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
n=66 Participants
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
65 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: The APT population consisted of all participants who received at least one dose of study drug.
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.
Outcome measures
| Measure |
SCH 900435 12 mg
n=75 Participants
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
n=66 Participants
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to an AE
|
6 Participants
|
3 Participants
|
Adverse Events
SCH 900435 12 mg
Placebo
Serious adverse events
| Measure |
SCH 900435 12 mg
n=75 participants at risk
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
n=66 participants at risk
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
VOMITING
|
1.3%
1/75 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/66 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
HEPATITIS CHOLESTATIC
|
1.3%
1/75 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/66 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
ABSCESS SWEAT GLAND
|
0.00%
0/75 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/75 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/75 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
PNEUMONIA PRIMARY ATYPICAL
|
1.3%
1/75 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/66 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
5.3%
4/75 • Number of events 4 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
6.1%
4/66 • Number of events 4 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.00%
0/75 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
BLOOD PRESSURE ABNORMAL
|
0.00%
0/75 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
CONVULSION
|
1.3%
1/75 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/66 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
GRAND MAL CONVULSION
|
1.3%
1/75 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/66 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/75 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
ALCOHOLISM
|
0.00%
0/75 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
DRUG WITHDRAWAL MAINTENANCE THERAPY
|
4.0%
3/75 • Number of events 3 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
1.3%
1/75 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/66 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
SCH 900435 12 mg
n=75 participants at risk
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
|
Placebo
n=66 participants at risk
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.3%
4/75 • Number of events 4 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Eye disorders
PHOTOPHOBIA
|
12.0%
9/75 • Number of events 9 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Eye disorders
PHOTOPSIA
|
8.0%
6/75 • Number of events 7 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
3.0%
2/66 • Number of events 2 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Eye disorders
VISION BLURRED
|
6.7%
5/75 • Number of events 6 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/66 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
9.3%
7/75 • Number of events 9 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
1.5%
1/66 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
8.0%
6/75 • Number of events 9 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
10.6%
7/66 • Number of events 8 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
DRY MOUTH
|
1.3%
1/75 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
6.1%
4/66 • Number of events 4 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
6.7%
5/75 • Number of events 7 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
9.1%
6/66 • Number of events 7 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
FATIGUE
|
25.3%
19/75 • Number of events 22 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
13.6%
9/66 • Number of events 9 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
INFLUENZA
|
8.0%
6/75 • Number of events 6 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
10.6%
7/66 • Number of events 7 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
NASOPHARYNGITIS
|
14.7%
11/75 • Number of events 18 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
27.3%
18/66 • Number of events 21 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.3%
1/75 • Number of events 1 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
7.6%
5/66 • Number of events 7 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
BALANCE DISORDER
|
6.7%
5/75 • Number of events 6 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/66 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
DIZZINESS
|
20.0%
15/75 • Number of events 19 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
4.5%
3/66 • Number of events 5 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
HEADACHE
|
17.3%
13/75 • Number of events 23 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
22.7%
15/66 • Number of events 17 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
TUNNEL VISION
|
5.3%
4/75 • Number of events 4 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/66 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
VISUAL FIELD DEFECT
|
5.3%
4/75 • Number of events 5 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
1.5%
1/66 • Number of events 2 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
INSOMNIA
|
8.0%
6/75 • Number of events 6 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
6.1%
4/66 • Number of events 6 • Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee In case the proposed publication contains reference to an invention owned by Organon or to which Organon otherwise has rights, Organon may request a reasonable suspension of the publication in order to be able to file a patent application protecting such invention.
- Publication restrictions are in place
Restriction type: OTHER