Trial Outcomes & Findings for Boceprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05685AM2)(COMPLETED) (NCT NCT00845065)
NCT ID: NCT00845065
Last Updated: 2017-04-07
Results Overview
SVR rate was the percentage of participants treated with at least one dose of study medication (PEG2a, Ribavirin, or Boceprevir/Placebo) who had achieved SVR. SVR was defined as undetectable Hepatitis C Virus-Ribonucleic Acid (HCV RNA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
202 participants
Primary outcome timeframe
Follow-up Week 24
Results posted on
2017-04-07
Participant Flow
A total of 202 participants were randomized but 1 participant was not treated.
Participant milestones
| Measure |
PEG2a/Ribavirin
Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously \[SC\]) plus ribavirin (1000 to 1200 mg/day orally \[PO\]) for 4 weeks followed by placebo (800 mg three times a day \[TID\] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir/PEG2a/Ribavirin
PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
134
|
|
Overall Study
COMPLETED
|
20
|
79
|
|
Overall Study
NOT COMPLETED
|
47
|
55
|
Reasons for withdrawal
| Measure |
PEG2a/Ribavirin
Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously \[SC\]) plus ribavirin (1000 to 1200 mg/day orally \[PO\]) for 4 weeks followed by placebo (800 mg three times a day \[TID\] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir/PEG2a/Ribavirin
PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
23
|
|
Overall Study
Lack of Efficacy
|
43
|
21
|
|
Overall Study
Non-Medical Reasons
|
1
|
11
|
Baseline Characteristics
Boceprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05685AM2)(COMPLETED)
Baseline characteristics by cohort
| Measure |
PEG2a/Ribavirin
n=67 Participants
Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously \[SC\]) plus ribavirin (1000 to 1200 mg/day orally \[PO\]) for 4 weeks followed by placebo (800 mg three times a day \[TID\] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir/PEG2a/Ribavirin
n=134 Participants
PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 6.8 • n=99 Participants
|
52.0 years
STANDARD_DEVIATION 7.2 • n=107 Participants
|
52.5 years
STANDARD_DEVIATION 7.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=99 Participants
|
97 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Follow-up Week 24Population: FAS Population: all randomized participants who received at least one dose of study medication (PEG2a, Ribavirin, or Boceprevir/Placebo). Follow-up (FU) Week (W) 12 value was Last Observation Carried Forward (LOCF), if last SVR value at or after FU W24 was not available.
SVR rate was the percentage of participants treated with at least one dose of study medication (PEG2a, Ribavirin, or Boceprevir/Placebo) who had achieved SVR. SVR was defined as undetectable Hepatitis C Virus-Ribonucleic Acid (HCV RNA).
Outcome measures
| Measure |
PEG2a/Ribavirin
n=67 Participants
Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously \[SC\]) plus ribavirin (1000 to 1200 mg/day orally \[PO\]) for 4 weeks followed by placebo (800 mg three times a day \[TID\] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir/PEG2a/Ribavirin
n=134 Participants
PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|
|
Sustained Virologic Response (SVR) Rate in Full Analysis Set (FAS) Population.
|
20.9 Percentage of Participants
|
64.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Follow-up Week 24Population: mITT Population: all randomized participants who received at least one dose of study medication (Boceprevir/PEG2a/Ribavirin or PEG2a/Ribavirin). Participants who discontinued study drugs during the 4-week PEG2a/Ribavirin lead-in period were not included. FU W12 value was LOCF, if last SVR value at or after FU W24 was not available.
SVR rate was the percentage of participants treated with at least one dose of study medication (Boceprevir/PEG2a/Ribavirin or PEG2a/Ribavirin). Participants who discontinued study drugs during the 4-week PEG2a/Ribavirin lead-in period were not included in the mITT population.
Outcome measures
| Measure |
PEG2a/Ribavirin
n=67 Participants
Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously \[SC\]) plus ribavirin (1000 to 1200 mg/day orally \[PO\]) for 4 weeks followed by placebo (800 mg three times a day \[TID\] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir/PEG2a/Ribavirin
n=130 Participants
PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|
|
SVR Rate in the Modified Intent-to-Treat (mITT) Population
|
20.9 Percentage of Participants
|
66.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 1 to Treatment Week 12Population: FAS Population
EVR was defined as the time to the first undectectable HCV-RNA result at Treatment Week (TW) 2, 4, 8, or 12. Participants with a detectable, but not quantifiable HCV-RNA result at TW 12 may have undergone retesting. Participants with a detectable result on retesting were to be discontinued per the 12-week futility rule. Participants with an undetectable result on retesting were allowed to continue on treatment, and the detectable but not quantifiable result was to be considered a false positive.
Outcome measures
| Measure |
PEG2a/Ribavirin
n=67 Participants
Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously \[SC\]) plus ribavirin (1000 to 1200 mg/day orally \[PO\]) for 4 weeks followed by placebo (800 mg three times a day \[TID\] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir/PEG2a/Ribavirin
n=134 Participants
PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|
|
Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR
<=TW 4 (PEG2a N = 2, Boceprevir N = 3)
|
50.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR
>TW 4 to TW 8 (PEG2a N = 7, Boceprevir N = 76)
|
42.9 Percentage of Participants
|
82.9 Percentage of Participants
|
|
Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR
>TW 8 to TW 12 (PEG2a N = 9, Boceprevir N = 22)
|
88.9 Percentage of Participants
|
68.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Follow-up Week 12Population: FAS Population
Outcome measures
| Measure |
PEG2a/Ribavirin
n=67 Participants
Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously \[SC\]) plus ribavirin (1000 to 1200 mg/day orally \[PO\]) for 4 weeks followed by placebo (800 mg three times a day \[TID\] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir/PEG2a/Ribavirin
n=134 Participants
PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|
|
Number of Participants With Undetectable HCV-RNA at Follow-up Week 12
|
12 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: From Baseline to TW 4Population: FAS Population
HCV-RNA levels were quantified using the Roche Cobas Taqman 1.0 assay; lower limit of detection of 15 international units \[IU\]/mL. Changes in HCV-RNA IU/ml were expressed on a log10 scale.
Outcome measures
| Measure |
PEG2a/Ribavirin
n=67 Participants
Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously \[SC\]) plus ribavirin (1000 to 1200 mg/day orally \[PO\]) for 4 weeks followed by placebo (800 mg three times a day \[TID\] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir/PEG2a/Ribavirin
n=134 Participants
PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|
|
Mean Log Change From Baseline to TW 4 in Viral Load by Visit
|
-2.44 log10 (IU/mL)
Standard Deviation 1.32
|
-2.33 log10 (IU/mL)
Standard Deviation 1.34
|
Adverse Events
PEG2a/Ribavirin
Serious events: 7 serious events
Other events: 67 other events
Deaths: 0 deaths
Boceprevir/PEG2a/Ribavirin
Serious events: 18 serious events
Other events: 133 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG2a/Ribavirin
n=67 participants at risk
Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously \[SC\]) plus ribavirin (1000 to 1200 mg/day orally \[PO\]) for 4 weeks followed by placebo (800 mg three times a day \[TID\] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir/PEG2a/Ribavirin
n=134 participants at risk
PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/67
|
1.5%
2/134 • Number of events 3
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
General disorders
ASTHENIA
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
General disorders
CHEST PAIN
|
1.5%
1/67 • Number of events 1
|
0.00%
0/134
|
|
General disorders
IRRITABILITY
|
1.5%
1/67 • Number of events 1
|
0.00%
0/134
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
General disorders
PYREXIA
|
0.00%
0/67
|
0.75%
1/134 • Number of events 2
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
Infections and infestations
CHLAMYDIAL INFECTION
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/67
|
1.5%
2/134 • Number of events 2
|
|
Infections and infestations
PNEUMONIA STAPHYLOCOCCAL
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
Injury, poisoning and procedural complications
FOREIGN BODY
|
1.5%
1/67 • Number of events 1
|
0.00%
0/134
|
|
Injury, poisoning and procedural complications
GUN SHOT WOUND
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/67
|
1.5%
2/134 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
1.5%
1/67 • Number of events 1
|
0.00%
0/134
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
Nervous system disorders
NEURALGIA
|
1.5%
1/67 • Number of events 1
|
0.00%
0/134
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/67
|
1.5%
2/134 • Number of events 2
|
|
Psychiatric disorders
ABNORMAL BEHAVIOUR
|
1.5%
1/67 • Number of events 1
|
0.00%
0/134
|
|
Psychiatric disorders
ANXIETY
|
1.5%
1/67 • Number of events 1
|
0.00%
0/134
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
|
Renal and urinary disorders
RENAL COLIC
|
1.5%
1/67 • Number of events 1
|
0.00%
0/134
|
|
Surgical and medical procedures
OSTEOTOMY
|
1.5%
1/67 • Number of events 1
|
0.00%
0/134
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/67
|
0.75%
1/134 • Number of events 1
|
Other adverse events
| Measure |
PEG2a/Ribavirin
n=67 participants at risk
Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously \[SC\]) plus ribavirin (1000 to 1200 mg/day orally \[PO\]) for 4 weeks followed by placebo (800 mg three times a day \[TID\] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir/PEG2a/Ribavirin
n=134 participants at risk
PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
32.8%
22/67 • Number of events 32
|
50.0%
67/134 • Number of events 119
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
3.0%
2/67 • Number of events 3
|
14.9%
20/134 • Number of events 43
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
17.9%
12/67 • Number of events 17
|
30.6%
41/134 • Number of events 89
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
6.0%
4/67 • Number of events 6
|
6.7%
9/134 • Number of events 12
|
|
Eye disorders
DRY EYE
|
1.5%
1/67 • Number of events 1
|
6.7%
9/134 • Number of events 9
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/67
|
5.2%
7/134 • Number of events 8
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
6.0%
4/67 • Number of events 5
|
8.2%
11/134 • Number of events 12
|
|
Gastrointestinal disorders
CONSTIPATION
|
7.5%
5/67 • Number of events 5
|
3.7%
5/134 • Number of events 5
|
|
Gastrointestinal disorders
DIARRHOEA
|
7.5%
5/67 • Number of events 5
|
24.6%
33/134 • Number of events 38
|
|
Gastrointestinal disorders
DRY MOUTH
|
3.0%
2/67 • Number of events 2
|
5.2%
7/134 • Number of events 7
|
|
Gastrointestinal disorders
DYSPEPSIA
|
4.5%
3/67 • Number of events 3
|
7.5%
10/134 • Number of events 11
|
|
Gastrointestinal disorders
NAUSEA
|
26.9%
18/67 • Number of events 19
|
38.8%
52/134 • Number of events 60
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/67
|
11.9%
16/134 • Number of events 21
|
|
General disorders
ASTHENIA
|
17.9%
12/67 • Number of events 15
|
21.6%
29/134 • Number of events 47
|
|
General disorders
CHILLS
|
11.9%
8/67 • Number of events 8
|
10.4%
14/134 • Number of events 24
|
|
General disorders
FATIGUE
|
53.7%
36/67 • Number of events 43
|
50.0%
67/134 • Number of events 80
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
26.9%
18/67 • Number of events 18
|
26.1%
35/134 • Number of events 37
|
|
General disorders
INJECTION SITE ERYTHEMA
|
6.0%
4/67 • Number of events 4
|
6.7%
9/134 • Number of events 9
|
|
General disorders
IRRITABILITY
|
23.9%
16/67 • Number of events 17
|
21.6%
29/134 • Number of events 34
|
|
General disorders
OEDEMA PERIPHERAL
|
4.5%
3/67 • Number of events 3
|
5.2%
7/134 • Number of events 8
|
|
General disorders
PAIN
|
3.0%
2/67 • Number of events 2
|
6.7%
9/134 • Number of events 10
|
|
General disorders
PYREXIA
|
11.9%
8/67 • Number of events 8
|
13.4%
18/134 • Number of events 39
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/67
|
6.0%
8/134 • Number of events 8
|
|
Investigations
WEIGHT DECREASED
|
6.0%
4/67 • Number of events 4
|
8.2%
11/134 • Number of events 12
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
17.9%
12/67 • Number of events 12
|
20.1%
27/134 • Number of events 28
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
17.9%
12/67 • Number of events 15
|
11.9%
16/134 • Number of events 22
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.5%
5/67 • Number of events 6
|
7.5%
10/134 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
7.5%
5/67 • Number of events 7
|
10.4%
14/134 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
7.5%
5/67 • Number of events 5
|
18.7%
25/134 • Number of events 32
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
1.5%
1/67 • Number of events 1
|
5.2%
7/134 • Number of events 8
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
6.0%
4/67 • Number of events 4
|
6.0%
8/134 • Number of events 9
|
|
Nervous system disorders
DIZZINESS
|
14.9%
10/67 • Number of events 10
|
12.7%
17/134 • Number of events 19
|
|
Nervous system disorders
DYSGEUSIA
|
14.9%
10/67 • Number of events 10
|
38.8%
52/134 • Number of events 53
|
|
Nervous system disorders
HEADACHE
|
31.3%
21/67 • Number of events 25
|
27.6%
37/134 • Number of events 46
|
|
Psychiatric disorders
ANXIETY
|
13.4%
9/67 • Number of events 9
|
11.9%
16/134 • Number of events 18
|
|
Psychiatric disorders
DEPRESSION
|
9.0%
6/67 • Number of events 7
|
16.4%
22/134 • Number of events 28
|
|
Psychiatric disorders
INSOMNIA
|
29.9%
20/67 • Number of events 21
|
23.9%
32/134 • Number of events 36
|
|
Psychiatric disorders
SLEEP DISORDER
|
4.5%
3/67 • Number of events 4
|
11.2%
15/134 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
20.9%
14/67 • Number of events 16
|
19.4%
26/134 • Number of events 32
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
25.4%
17/67 • Number of events 17
|
19.4%
26/134 • Number of events 28
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
7.5%
5/67 • Number of events 5
|
9.7%
13/134 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
1.5%
1/67 • Number of events 1
|
9.7%
13/134 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
7.5%
5/67 • Number of events 5
|
16.4%
22/134 • Number of events 24
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
16.4%
11/67 • Number of events 13
|
14.9%
20/134 • Number of events 22
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
11.9%
8/67 • Number of events 9
|
13.4%
18/134 • Number of events 23
|
|
Skin and subcutaneous tissue disorders
RASH
|
7.5%
5/67 • Number of events 5
|
23.1%
31/134 • Number of events 37
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator agrees not to present any interim results of study without prior written consent of sponsor. Investigator agrees to provide sponsor 45 days prior to submission publication, review copies of abstracts/manuscripts that report any results of the study. Sponsor shall have the right to review/comment on data analysis. If parties disagree investigator agrees to meet with sponsor's representatives at clinical study site for purpose of making good faith efforts to resolve any such issues.
- Publication restrictions are in place
Restriction type: OTHER