Trial Outcomes & Findings for Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212) (NCT NCT00255008)
NCT ID: NCT00255008
Last Updated: 2017-04-06
Results Overview
SVR is defined as negative hepatitis C virus ribonucleic acid (HCV RNA) in serum at 24 weeks after therapy completion. The study was terminated early due to slow enrollment. The primary outcome measure could not be assessed.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
121 participants
Primary outcome timeframe
24 weeks after completion of either up to 24 or 48 weeks of therapy
Results posted on
2017-04-06
Participant Flow
Participant milestones
| Measure |
Genotype 1 SEA PEG-IFN/RIB 48 w
Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
|
Genotype 1 Caucasian PEG-IFN/RIB 48 w
Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
|
Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w
Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
|
Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w
Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
45
|
9
|
33
|
34
|
|
Overall Study
COMPLETED
|
13
|
0
|
17
|
12
|
|
Overall Study
NOT COMPLETED
|
32
|
9
|
16
|
22
|
Reasons for withdrawal
| Measure |
Genotype 1 SEA PEG-IFN/RIB 48 w
Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
|
Genotype 1 Caucasian PEG-IFN/RIB 48 w
Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
|
Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w
Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
|
Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w
Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
2
|
|
Overall Study
Did not meet viral reduction criteria
|
4
|
5
|
0
|
1
|
|
Overall Study
Withdrew consent
|
0
|
0
|
2
|
0
|
|
Overall Study
Sponsor request
|
18
|
3
|
8
|
17
|
|
Overall Study
Adverse lab experience
|
1
|
0
|
0
|
0
|
|
Overall Study
Other
|
7
|
0
|
3
|
2
|
Baseline Characteristics
Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212)
Baseline characteristics by cohort
| Measure |
Genotype 1 SEA PEG-IFN/RIB 48 w
n=45 Participants
Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
|
Genotype 1 Caucasian PEG-IFN/RIB 48 w
n=9 Participants
Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
|
Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w
n=33 Participants
Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
|
Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w
n=34 Participants
Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 11.06 • n=5 Participants
|
43.6 years
STANDARD_DEVIATION 12.30 • n=7 Participants
|
46.8 years
STANDARD_DEVIATION 10.56 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 10.71 • n=4 Participants
|
45.2 years
STANDARD_DEVIATION 10.89 • n=21 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after completion of either up to 24 or 48 weeks of therapyPopulation: The study was terminated early due to slow enrollment. The primary outcome measure should be assessed with caution. No data was available at 24 weeks after therapy for the Genotype 1 Caucasian treatment group.
SVR is defined as negative hepatitis C virus ribonucleic acid (HCV RNA) in serum at 24 weeks after therapy completion. The study was terminated early due to slow enrollment. The primary outcome measure could not be assessed.
Outcome measures
| Measure |
Genotype 1 SEA PEG-IFN/RIB 48 w
n=5 Participants
Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
|
Genotype 1 Caucasian PEG-IFN/RIB 48 w
Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
|
Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w
n=17 Participants
Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
|
Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w
n=8 Participants
Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
|
|---|---|---|---|---|
|
Number of Subjects Who Achieved a Sustained Virologic Response (SVR)
|
4 Participants
|
—
|
13 Participants
|
7 Participants
|
Adverse Events
Genotype 1 SEA PEG-IFN/RIB 48w
Serious events: 2 serious events
Other events: 42 other events
Deaths: 0 deaths
Genotype 1 Caucasian PEG-IFN/RIB 48w
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Genotype 6,7,8,9 SEA PEG-IFN/RIB 24w
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
Genotype 6,7,8,9 SEA PEG-IFN/RIB 48w
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Genotype 1 SEA PEG-IFN/RIB 48w
n=45 participants at risk
|
Genotype 1 Caucasian PEG-IFN/RIB 48w
n=9 participants at risk
|
Genotype 6,7,8,9 SEA PEG-IFN/RIB 24w
n=33 participants at risk
|
Genotype 6,7,8,9 SEA PEG-IFN/RIB 48w
n=34 participants at risk
|
|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/45
|
0.00%
0/9
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/45
|
0.00%
0/9
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
NAUSEA
|
2.2%
1/45 • Number of events 1
|
0.00%
0/9
|
0.00%
0/33
|
0.00%
0/34
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/45
|
0.00%
0/9
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
General disorders
FATIGUE
|
2.2%
1/45 • Number of events 1
|
0.00%
0/9
|
0.00%
0/33
|
0.00%
0/34
|
|
General disorders
PYREXIA
|
0.00%
0/45
|
0.00%
0/9
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/45
|
0.00%
0/9
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/45
|
0.00%
0/9
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
Injury, poisoning and procedural complications
COLLAPSE OF LUNG
|
0.00%
0/45
|
0.00%
0/9
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.00%
0/45
|
0.00%
0/9
|
0.00%
0/33
|
2.9%
1/34 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
2.2%
1/45 • Number of events 1
|
0.00%
0/9
|
0.00%
0/33
|
0.00%
0/34
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/45
|
0.00%
0/9
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
Other adverse events
| Measure |
Genotype 1 SEA PEG-IFN/RIB 48w
n=45 participants at risk
|
Genotype 1 Caucasian PEG-IFN/RIB 48w
n=9 participants at risk
|
Genotype 6,7,8,9 SEA PEG-IFN/RIB 24w
n=33 participants at risk
|
Genotype 6,7,8,9 SEA PEG-IFN/RIB 48w
n=34 participants at risk
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
13.3%
6/45 • Number of events 7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/33
|
2.9%
1/34 • Number of events 1
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
2.2%
1/45 • Number of events 4
|
0.00%
0/9
|
6.1%
2/33 • Number of events 2
|
0.00%
0/34
|
|
Ear and labyrinth disorders
EAR DISORDER
|
2.2%
1/45 • Number of events 1
|
0.00%
0/9
|
0.00%
0/33
|
5.9%
2/34 • Number of events 2
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/45
|
11.1%
1/9 • Number of events 1
|
0.00%
0/33
|
0.00%
0/34
|
|
Endocrine disorders
HYPERTHYROIDISM
|
4.4%
2/45 • Number of events 2
|
0.00%
0/9
|
6.1%
2/33 • Number of events 2
|
0.00%
0/34
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.00%
0/45
|
0.00%
0/9
|
6.1%
2/33 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
|
Eye disorders
DRY EYE
|
4.4%
2/45 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
|
Eye disorders
VISION BLURRED
|
2.2%
1/45 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/45
|
11.1%
1/9 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
4.4%
2/45 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
CONSTIPATION
|
6.7%
3/45 • Number of events 3
|
0.00%
0/9
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
DIARRHOEA
|
11.1%
5/45 • Number of events 5
|
22.2%
2/9 • Number of events 3
|
15.2%
5/33 • Number of events 6
|
23.5%
8/34 • Number of events 9
|
|
Gastrointestinal disorders
DRY MOUTH
|
6.7%
3/45 • Number of events 3
|
0.00%
0/9
|
21.2%
7/33 • Number of events 7
|
20.6%
7/34 • Number of events 7
|
|
Gastrointestinal disorders
DYSPEPSIA
|
6.7%
3/45 • Number of events 3
|
0.00%
0/9
|
3.0%
1/33 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
DYSPHAGIA
|
2.2%
1/45 • Number of events 2
|
0.00%
0/9
|
6.1%
2/33 • Number of events 2
|
0.00%
0/34
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
2.2%
1/45 • Number of events 1
|
0.00%
0/9
|
3.0%
1/33 • Number of events 1
|
11.8%
4/34 • Number of events 4
|
|
Gastrointestinal disorders
NAUSEA
|
11.1%
5/45 • Number of events 6
|
44.4%
4/9 • Number of events 4
|
27.3%
9/33 • Number of events 10
|
32.4%
11/34 • Number of events 11
|
|
Gastrointestinal disorders
ORAL PAIN
|
2.2%
1/45 • Number of events 1
|
0.00%
0/9
|
6.1%
2/33 • Number of events 2
|
0.00%
0/34
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/45
|
0.00%
0/9
|
3.0%
1/33 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
|
General disorders
AXILLARY PAIN
|
0.00%
0/45
|
11.1%
1/9 • Number of events 2
|
0.00%
0/33
|
0.00%
0/34
|
|
General disorders
CHEST PAIN
|
0.00%
0/45
|
11.1%
1/9 • Number of events 1
|
0.00%
0/33
|
0.00%
0/34
|
|
General disorders
CHILLS
|
2.2%
1/45 • Number of events 1
|
22.2%
2/9 • Number of events 4
|
3.0%
1/33 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
|
General disorders
FATIGUE
|
35.6%
16/45 • Number of events 17
|
88.9%
8/9 • Number of events 8
|
36.4%
12/33 • Number of events 12
|
32.4%
11/34 • Number of events 11
|
|
General disorders
FEELING COLD
|
0.00%
0/45
|
0.00%
0/9
|
0.00%
0/33
|
5.9%
2/34 • Number of events 2
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
28.9%
13/45 • Number of events 13
|
55.6%
5/9 • Number of events 5
|
60.6%
20/33 • Number of events 21
|
47.1%
16/34 • Number of events 17
|
|
General disorders
INJECTION SITE ERYTHEMA
|
15.6%
7/45 • Number of events 7
|
33.3%
3/9 • Number of events 3
|
27.3%
9/33 • Number of events 9
|
32.4%
11/34 • Number of events 11
|
|
General disorders
INJECTION SITE RASH
|
8.9%
4/45 • Number of events 5
|
0.00%
0/9
|
3.0%
1/33 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
|
General disorders
INJECTION SITE REACTION
|
2.2%
1/45 • Number of events 1
|
0.00%
0/9
|
3.0%
1/33 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
|
General disorders
IRRITABILITY
|
6.7%
3/45 • Number of events 3
|
44.4%
4/9 • Number of events 4
|
18.2%
6/33 • Number of events 6
|
8.8%
3/34 • Number of events 3
|
|
General disorders
MALAISE
|
8.9%
4/45 • Number of events 4
|
0.00%
0/9
|
0.00%
0/33
|
0.00%
0/34
|
|
General disorders
PYREXIA
|
28.9%
13/45 • Number of events 13
|
0.00%
0/9
|
15.2%
5/33 • Number of events 5
|
20.6%
7/34 • Number of events 7
|
|
General disorders
THIRST
|
6.7%
3/45 • Number of events 3
|
0.00%
0/9
|
6.1%
2/33 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
|
General disorders
ULCER
|
0.00%
0/45
|
11.1%
1/9 • Number of events 1
|
0.00%
0/33
|
0.00%
0/34
|
|
Immune system disorders
SEASONAL ALLERGY
|
4.4%
2/45 • Number of events 2
|
0.00%
0/9
|
9.1%
3/33 • Number of events 3
|
8.8%
3/34 • Number of events 3
|
|
Infections and infestations
HERPES SIMPLEX
|
2.2%
1/45 • Number of events 1
|
0.00%
0/9
|
0.00%
0/33
|
8.8%
3/34 • Number of events 3
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/45
|
22.2%
2/9 • Number of events 2
|
0.00%
0/33
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
2.2%
1/45 • Number of events 1
|
0.00%
0/9
|
3.0%
1/33 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.2%
1/45 • Number of events 1
|
0.00%
0/9
|
9.1%
3/33 • Number of events 4
|
0.00%
0/34
|
|
Investigations
HAEMOGLOBIN DECREASED
|
8.9%
4/45 • Number of events 5
|
11.1%
1/9 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
14.7%
5/34 • Number of events 5
|
|
Investigations
LYMPH NODE PALPABLE
|
0.00%
0/45
|
11.1%
1/9 • Number of events 1
|
0.00%
0/33
|
0.00%
0/34
|
|
Investigations
WEIGHT DECREASED
|
20.0%
9/45 • Number of events 9
|
0.00%
0/9
|
0.00%
0/33
|
2.9%
1/34 • Number of events 1
|
|
Metabolism and nutrition disorders
ANOREXIA
|
13.3%
6/45 • Number of events 6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/33
|
8.8%
3/34 • Number of events 3
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
26.7%
12/45 • Number of events 13
|
77.8%
7/9 • Number of events 7
|
42.4%
14/33 • Number of events 14
|
50.0%
17/34 • Number of events 17
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/45
|
0.00%
0/9
|
6.1%
2/33 • Number of events 2
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.7%
3/45 • Number of events 3
|
11.1%
1/9 • Number of events 1
|
21.2%
7/33 • Number of events 7
|
5.9%
2/34 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.7%
3/45 • Number of events 3
|
11.1%
1/9 • Number of events 1
|
21.2%
7/33 • Number of events 7
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISCOMFORT
|
0.00%
0/45
|
11.1%
1/9 • Number of events 1
|
0.00%
0/33
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
0.00%
0/45
|
11.1%
1/9 • Number of events 1
|
0.00%
0/33
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
17.8%
8/45 • Number of events 10
|
44.4%
4/9 • Number of events 4
|
33.3%
11/33 • Number of events 11
|
32.4%
11/34 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/45
|
0.00%
0/9
|
3.0%
1/33 • Number of events 2
|
11.8%
4/34 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
SHOULDER PAIN
|
0.00%
0/45
|
11.1%
1/9 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Nervous system disorders
AMNESIA
|
2.2%
1/45 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
6.1%
2/33 • Number of events 2
|
8.8%
3/34 • Number of events 3
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
2.2%
1/45 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
6.1%
2/33 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
|
Nervous system disorders
DIZZINESS
|
20.0%
9/45 • Number of events 11
|
33.3%
3/9 • Number of events 3
|
24.2%
8/33 • Number of events 8
|
38.2%
13/34 • Number of events 14
|
|
Nervous system disorders
DYSGEUSIA
|
8.9%
4/45 • Number of events 4
|
22.2%
2/9 • Number of events 2
|
6.1%
2/33 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
|
Nervous system disorders
HEADACHE
|
20.0%
9/45 • Number of events 12
|
11.1%
1/9 • Number of events 1
|
42.4%
14/33 • Number of events 14
|
38.2%
13/34 • Number of events 14
|
|
Nervous system disorders
LETHARGY
|
13.3%
6/45 • Number of events 6
|
0.00%
0/9
|
42.4%
14/33 • Number of events 17
|
38.2%
13/34 • Number of events 14
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/45
|
0.00%
0/9
|
3.0%
1/33 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/45
|
0.00%
0/9
|
6.1%
2/33 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
|
Psychiatric disorders
DEPRESSED MOOD
|
2.2%
1/45 • Number of events 1
|
44.4%
4/9 • Number of events 4
|
15.2%
5/33 • Number of events 5
|
5.9%
2/34 • Number of events 2
|
|
Psychiatric disorders
DISORIENTATION
|
0.00%
0/45
|
11.1%
1/9 • Number of events 1
|
0.00%
0/33
|
0.00%
0/34
|
|
Psychiatric disorders
INSOMNIA
|
31.1%
14/45 • Number of events 17
|
44.4%
4/9 • Number of events 5
|
48.5%
16/33 • Number of events 16
|
41.2%
14/34 • Number of events 15
|
|
Psychiatric disorders
MOOD ALTERED
|
6.7%
3/45 • Number of events 3
|
0.00%
0/9
|
3.0%
1/33 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
|
Psychiatric disorders
MOOD SWINGS
|
4.4%
2/45 • Number of events 2
|
0.00%
0/9
|
6.1%
2/33 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
|
Psychiatric disorders
SLEEP DISORDER
|
6.7%
3/45 • Number of events 3
|
11.1%
1/9 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
11.8%
4/34 • Number of events 5
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.00%
0/45
|
11.1%
1/9 • Number of events 1
|
0.00%
0/33
|
0.00%
0/34
|
|
Reproductive system and breast disorders
GENITAL HAEMORRHAGE
|
0.00%
0/45
|
11.1%
1/9 • Number of events 1
|
0.00%
0/33
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
8.9%
4/45 • Number of events 5
|
0.00%
0/9
|
18.2%
6/33 • Number of events 6
|
11.8%
4/34 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
DRY THROAT
|
2.2%
1/45 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
8.9%
4/45 • Number of events 4
|
22.2%
2/9 • Number of events 2
|
6.1%
2/33 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
8.9%
4/45 • Number of events 4
|
11.1%
1/9 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
37.8%
17/45 • Number of events 17
|
22.2%
2/9 • Number of events 2
|
33.3%
11/33 • Number of events 11
|
50.0%
17/34 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
26.7%
12/45 • Number of events 13
|
66.7%
6/9 • Number of events 6
|
39.4%
13/33 • Number of events 13
|
32.4%
11/34 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
28.9%
13/45 • Number of events 19
|
66.7%
6/9 • Number of events 6
|
33.3%
11/33 • Number of events 11
|
26.5%
9/34 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
RASH
|
8.9%
4/45 • Number of events 4
|
22.2%
2/9 • Number of events 2
|
24.2%
8/33 • Number of events 10
|
23.5%
8/34 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/45
|
11.1%
1/9 • Number of events 1
|
0.00%
0/33
|
0.00%
0/34
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.00%
0/45
|
0.00%
0/9
|
0.00%
0/33
|
5.9%
2/34 • Number of events 2
|
|
Surgical and medical procedures
HERNIA REPAIR
|
0.00%
0/45
|
11.1%
1/9 • Number of events 1
|
0.00%
0/33
|
0.00%
0/34
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/45
|
0.00%
0/9
|
0.00%
0/33
|
5.9%
2/34 • Number of events 2
|
|
Vascular disorders
PALLOR
|
6.7%
3/45 • Number of events 4
|
0.00%
0/9
|
0.00%
0/33
|
0.00%
0/34
|
Additional Information
Senior Vice President, Global Clinical Development
Merck, Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60