Trial Outcomes & Findings for Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427) (NCT NCT00724854)
NCT ID: NCT00724854
Last Updated: 2015-02-25
Results Overview
Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment.
Recruitment status
COMPLETED
Target enrollment
1146 participants
Primary outcome timeframe
Assessed at Treatment Week 4
Results posted on
2015-02-25
Participant Flow
Participant milestones
| Measure |
Mono-infected With HCV
Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
Co-infected With HCV and HIV
Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
|---|---|---|
|
Overall Study
STARTED
|
1010
|
72
|
|
Overall Study
COMPLETED
|
607
|
41
|
|
Overall Study
NOT COMPLETED
|
403
|
31
|
Reasons for withdrawal
| Measure |
Mono-infected With HCV
Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
Co-infected With HCV and HIV
Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
187
|
13
|
|
Overall Study
Lost to Follow-up
|
87
|
10
|
|
Overall Study
Adverse Event
|
62
|
4
|
|
Overall Study
Other
|
42
|
3
|
|
Overall Study
Death
|
11
|
0
|
|
Overall Study
Change of treatment
|
7
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
|
Overall Study
Adverse event + lack of efficacy
|
2
|
1
|
Baseline Characteristics
Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427)
Baseline characteristics by cohort
| Measure |
Mono-infected With HCV
n=1010 Participants
Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
Co-infected With HCV and HIV
n=72 Participants
Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
Total
n=1082 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=40 years
|
193 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Age, Customized
>40 years
|
817 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
853 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
444 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
467 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
566 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
615 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
1010 participants
n=5 Participants
|
72 participants
n=7 Participants
|
1082 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at Treatment Week 4Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment.
Outcome measures
| Measure |
Mono-infected With HCV
n=1010 Participants
Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
Co-infected With HCV and HIV
n=72 Participants
Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
|---|---|---|
|
Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment
|
551 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Assessed at 24 weeks post-treatmentSVR was defined as non-detectable HCV RNA 24 weeks post-treatment.
Outcome measures
| Measure |
Mono-infected With HCV
n=1010 Participants
Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
Co-infected With HCV and HIV
n=72 Participants
Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
|---|---|---|
|
Number of Participants Who Achieved Sustained Virologic Response (SVR)
|
375 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR)Population: Participants who achieved RVR at Treatment Week 4.
RVR was defined as HCV RNA negative after 4 weeks of treatment. SVR was defined as non-detectable HCV RNA 24 weeks or more post-treatment.
Outcome measures
| Measure |
Mono-infected With HCV
n=551 Participants
Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
Co-infected With HCV and HIV
n=32 Participants
Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
|---|---|---|
|
Number of Participants With RVR Who Also Achieved SVR
|
300 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Treatment Week 48 and Treatment Week 72Population: Participants who achieved RVR at Treatment Week 4.
Participants who achieved RVR at Treatment Week 4 who were considered to have SVR (non-detectable HCV RNA at Treatment Week 48 for genotypes 2 and 3, and Treatment Week 72 for genotypes 1, 4, and 5). Participants from the Mono-infected with HCV group and the Co-infected with HCV and HIV group, were identified as either Genotype 1, 2, 3, 4, or 5.
Outcome measures
| Measure |
Mono-infected With HCV
n=551 Participants
Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
Co-infected With HCV and HIV
n=32 Participants
Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
|---|---|---|
|
Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR
No SVR
|
251 Participants
|
13 Participants
|
|
Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR
SVR
|
300 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 24 Weeks post-treatmentPopulation: Participants with SVR
Baseline characteristics assessed were age, gender, and genotype.
Outcome measures
| Measure |
Mono-infected With HCV
n=375 Participants
Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
Co-infected With HCV and HIV
n=24 Participants
Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
|---|---|---|
|
Assessment of Baseline Characteristics in Participants With SVR
Age <=40 years
|
75 Participants
|
11 Participants
|
|
Assessment of Baseline Characteristics in Participants With SVR
Age >40 years
|
300 Participants
|
13 Participants
|
|
Assessment of Baseline Characteristics in Participants With SVR
male
|
203 Participants
|
17 Participants
|
|
Assessment of Baseline Characteristics in Participants With SVR
female
|
172 Participants
|
7 Participants
|
|
Assessment of Baseline Characteristics in Participants With SVR
Genotype 1
|
247 Participants
|
14 Participants
|
|
Assessment of Baseline Characteristics in Participants With SVR
Genotype non-1
|
128 Participants
|
10 Participants
|
Adverse Events
Mono-Infected With HCV
Serious events: 52 serious events
Other events: 762 other events
Deaths: 0 deaths
Co-Infected With HCV and HIV
Serious events: 0 serious events
Other events: 61 other events
Deaths: 0 deaths
Not Evaluated
Serious events: 8 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mono-Infected With HCV
n=1010 participants at risk
Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
Co-Infected With HCV and HIV
n=72 participants at risk
Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
Not Evaluated
n=64 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.79%
8/1010 • Number of events 8
|
0.00%
0/72
|
0.00%
0/64
|
|
Blood and lymphatic system disorders
HAEMOLYTIC ANAEMIA
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/1010
|
0.00%
0/72
|
1.6%
1/64 • Number of events 1
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.20%
2/1010 • Number of events 2
|
0.00%
0/72
|
0.00%
0/64
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Ear and labyrinth disorders
HYPOACUSIS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Eye disorders
RETINAL DETACHMENT
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.30%
3/1010 • Number of events 3
|
0.00%
0/72
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
ASCITES
|
0.20%
2/1010 • Number of events 2
|
0.00%
0/72
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
3.1%
2/64 • Number of events 2
|
|
Gastrointestinal disorders
FAECALOMA
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Gastrointestinal disorders
MELAENA
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Gastrointestinal disorders
OESOPHAGEAL ULCER HAEMORRHAGE
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Gastrointestinal disorders
PERITONITIS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Gastrointestinal disorders
STOMATITIS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/1010
|
0.00%
0/72
|
1.6%
1/64 • Number of events 1
|
|
General disorders
ASTHENIA
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
General disorders
DEATH
|
0.20%
2/1010 • Number of events 2
|
0.00%
0/72
|
0.00%
0/64
|
|
General disorders
FATIGUE
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
General disorders
MALAISE
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
General disorders
PYREXIA
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
1.6%
1/64 • Number of events 1
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Hepatobiliary disorders
CHOLESTASIS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Hepatobiliary disorders
JAUNDICE
|
0.20%
2/1010 • Number of events 2
|
0.00%
0/72
|
0.00%
0/64
|
|
Infections and infestations
APPENDICITIS
|
0.40%
4/1010 • Number of events 4
|
0.00%
0/72
|
0.00%
0/64
|
|
Infections and infestations
CELLULITIS
|
0.10%
1/1010 • Number of events 4
|
0.00%
0/72
|
0.00%
0/64
|
|
Infections and infestations
CENTRAL NERVOUS SYSTEM ABSCESS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Infections and infestations
PNEUMONIA
|
0.20%
2/1010 • Number of events 2
|
0.00%
0/72
|
0.00%
0/64
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Infections and infestations
SEPSIS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.30%
3/1010 • Number of events 3
|
0.00%
0/72
|
0.00%
0/64
|
|
Infections and infestations
UROSEPSIS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Injury, poisoning and procedural complications
INJURY
|
0.20%
2/1010 • Number of events 2
|
0.00%
0/72
|
0.00%
0/64
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.20%
2/1010 • Number of events 2
|
0.00%
0/72
|
0.00%
0/64
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Nervous system disorders
ASTERIXIS
|
0.00%
0/1010
|
0.00%
0/72
|
1.6%
1/64 • Number of events 1
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Nervous system disorders
DIZZINESS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Nervous system disorders
HEPATIC ENCEPHALOPATHY
|
0.30%
3/1010 • Number of events 3
|
0.00%
0/72
|
0.00%
0/64
|
|
Nervous system disorders
OPTIC NEURITIS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Nervous system disorders
QUADRIPLEGIA
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/1010
|
0.00%
0/72
|
3.1%
2/64 • Number of events 2
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.20%
2/1010 • Number of events 2
|
0.00%
0/72
|
0.00%
0/64
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/1010
|
0.00%
0/72
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.40%
4/1010 • Number of events 4
|
0.00%
0/72
|
0.00%
0/64
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Surgical and medical procedures
LEG AMPUTATION
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
0.00%
0/64
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
1.6%
1/64 • Number of events 1
|
|
Vascular disorders
HYPOTENSION
|
0.20%
2/1010 • Number of events 2
|
0.00%
0/72
|
0.00%
0/64
|
|
Vascular disorders
THROMBOPHLEBITIS
|
0.10%
1/1010 • Number of events 1
|
0.00%
0/72
|
1.6%
1/64 • Number of events 1
|
Other adverse events
| Measure |
Mono-Infected With HCV
n=1010 participants at risk
Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
Co-Infected With HCV and HIV
n=72 participants at risk
Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
|
Not Evaluated
n=64 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
16.3%
165/1010 • Number of events 171
|
25.0%
18/72 • Number of events 19
|
7.8%
5/64 • Number of events 6
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
3.8%
38/1010 • Number of events 39
|
8.3%
6/72 • Number of events 6
|
1.6%
1/64 • Number of events 1
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
5.8%
59/1010 • Number of events 60
|
9.7%
7/72 • Number of events 9
|
7.8%
5/64 • Number of events 5
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
3.4%
34/1010 • Number of events 34
|
6.9%
5/72 • Number of events 5
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
6.2%
63/1010 • Number of events 65
|
8.3%
6/72 • Number of events 6
|
4.7%
3/64 • Number of events 3
|
|
Gastrointestinal disorders
DIARRHOEA
|
7.5%
76/1010 • Number of events 77
|
11.1%
8/72 • Number of events 8
|
10.9%
7/64 • Number of events 8
|
|
Gastrointestinal disorders
NAUSEA
|
12.1%
122/1010 • Number of events 138
|
11.1%
8/72 • Number of events 11
|
9.4%
6/64 • Number of events 6
|
|
Gastrointestinal disorders
VOMITING
|
4.2%
42/1010 • Number of events 44
|
6.9%
5/72 • Number of events 5
|
3.1%
2/64 • Number of events 3
|
|
General disorders
ASTHENIA
|
28.1%
284/1010 • Number of events 309
|
19.4%
14/72 • Number of events 15
|
26.6%
17/64 • Number of events 17
|
|
General disorders
FATIGUE
|
10.4%
105/1010 • Number of events 110
|
12.5%
9/72 • Number of events 9
|
6.2%
4/64 • Number of events 4
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
13.1%
132/1010 • Number of events 136
|
2.8%
2/72 • Number of events 2
|
14.1%
9/64 • Number of events 9
|
|
General disorders
IRRITABILITY
|
9.8%
99/1010 • Number of events 99
|
12.5%
9/72 • Number of events 9
|
3.1%
2/64 • Number of events 2
|
|
General disorders
MALAISE
|
5.6%
57/1010 • Number of events 58
|
6.9%
5/72 • Number of events 6
|
4.7%
3/64 • Number of events 3
|
|
General disorders
PYREXIA
|
27.1%
274/1010 • Number of events 292
|
45.8%
33/72 • Number of events 37
|
21.9%
14/64 • Number of events 15
|
|
Investigations
WEIGHT DECREASED
|
7.1%
72/1010 • Number of events 72
|
11.1%
8/72 • Number of events 8
|
1.6%
1/64 • Number of events 1
|
|
Metabolism and nutrition disorders
ANOREXIA
|
12.5%
126/1010 • Number of events 129
|
20.8%
15/72 • Number of events 15
|
10.9%
7/64 • Number of events 7
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
6.2%
63/1010 • Number of events 68
|
9.7%
7/72 • Number of events 7
|
4.7%
3/64 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.7%
78/1010 • Number of events 86
|
15.3%
11/72 • Number of events 12
|
0.00%
0/64
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
27.7%
280/1010 • Number of events 302
|
45.8%
33/72 • Number of events 34
|
18.8%
12/64 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
3.2%
32/1010 • Number of events 34
|
5.6%
4/72 • Number of events 4
|
6.2%
4/64 • Number of events 4
|
|
Nervous system disorders
DIZZINESS
|
6.8%
69/1010 • Number of events 71
|
4.2%
3/72 • Number of events 3
|
3.1%
2/64 • Number of events 2
|
|
Nervous system disorders
HEADACHE
|
25.4%
257/1010 • Number of events 295
|
26.4%
19/72 • Number of events 21
|
15.6%
10/64 • Number of events 10
|
|
Psychiatric disorders
DEPRESSION
|
9.9%
100/1010 • Number of events 100
|
12.5%
9/72 • Number of events 10
|
14.1%
9/64 • Number of events 9
|
|
Psychiatric disorders
INSOMNIA
|
9.3%
94/1010 • Number of events 95
|
5.6%
4/72 • Number of events 4
|
4.7%
3/64 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
8.3%
84/1010 • Number of events 86
|
8.3%
6/72 • Number of events 6
|
4.7%
3/64 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
9.2%
93/1010 • Number of events 93
|
11.1%
8/72 • Number of events 8
|
4.7%
3/64 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
13.9%
140/1010 • Number of events 146
|
8.3%
6/72 • Number of events 6
|
6.2%
4/64 • Number of events 4
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Whenever a Principal Investigator wishes to use the results of the study, he/she should contact the sponsor to obtain the authorization.
- Publication restrictions are in place
Restriction type: OTHER