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Efficacy of Polyethylene Glycol-Interferon Alfa-2B (PEG-Intron, SCH 54031) Compared to Interferon Alfa-2B in Participants With Chronic Hepatitis C (MK-4031-016)

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ClinicalTrials.gov Identifier: NCT03537274
Recruitment Status : Completed
First Posted : May 25, 2018
Results First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Biological: PEG-Intron
Biological: Interferon Alfa-2B
Enrollment 1224
Recruitment Details In total, 1224 participants with chronic Hepatitis C virus (HCV) infection were randomized, with 1219 receiving study treatment.
Pre-assignment Details  
Arm/Group Title PEG-Intron, 0.5 mg/kg PEG-Intron, 1.0 mg/kg PEG-Intron, 1.5 mg/kg Interferon Alfa-2b
Hide Arm/Group Description PEG-Intron administered once weekly (QW) for 48 weeks at 0.5 mg/kg by subcutaneous (SC) injection. PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection. PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection. Interferon Alfa-2b administered three times per week (TIW) for 48 weeks at 3 million international units (MIU) by SC injection.
Period Title: Overall Study
Started 315 298 304 307
Treated 315 297 304 303
Completed 255 229 228 231
Not Completed 60 69 76 76
Arm/Group Title PEG-Intron, 0.5 mg/kg PEG-Intron, 1.0 mg/kg PEG-Intron, 1.5 mg/kg Interferon Alfa-2b Total
Hide Arm/Group Description PEG-Intron administered QW for 48 weeks at 0.5 mg/kg by SC injection. PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection. PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection. Interferon Alfa-2b administered TIW for 48 weeks at 3 MIU by SC injection. Total of all reporting groups
Overall Number of Baseline Participants 315 297 304 303 1219
Hide Baseline Analysis Population Description
Includes all randomized participants receiving ≥1 dose of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 315 participants 297 participants 304 participants 303 participants 1219 participants
43.1  (9.4) 43.7  (9.5) 42.9  (8.7) 42.6  (9.2) 43.1  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 315 participants 297 participants 304 participants 303 participants 1219 participants
Female
130
  41.3%
109
  36.7%
114
  37.5%
96
  31.7%
449
  36.8%
Male
185
  58.7%
188
  63.3%
190
  62.5%
207
  68.3%
770
  63.2%
1.Primary Outcome
Title Number of Participants Achieving Responder Status at 24 Weeks of Treatment
Hide Description The number of participants achieving responder status at 24 weeks of treatment was assessed. A participant was classified as a responder if, at 24 weeks of treatment, they met both of the following criteria: 1) HCV-Ribonucleic Acid (RNA) negative (defined as <100 copies/mL serum by quantitative polymerase chain reaction [qPCR] assay); and 2) alanine transaminase (ALT) level normal.
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all randomized participants receiving ≥1 dose of study treatment.
Arm/Group Title PEG-Intron, 0.5 mg/kg PEG-Intron, 1.0 mg/kg PEG-Intron, 1.5 mg/kg Interferon Alfa-2b
Hide Arm/Group Description:
PEG-Intron administered QW for 48 weeks at 0.5 mg/kg by SC injection.
PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection.
PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection.
Interferon Alfa-2b administered TIW for 48 weeks at 3 MIU by SC injection.
Overall Number of Participants Analyzed 315 297 304 303
Measure Type: Count of Participants
Unit of Measure: Participants
80
  25.4%
87
  29.3%
90
  29.6%
59
  19.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-Intron, 0.5 mg/kg, Interferon Alfa-2b
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PEG-Intron, 1.0 mg/kg, Interferon Alfa-2b
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PEG-Intron, 1.5 mg/kg, Interferon Alfa-2b
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Number of Participants Achieving Sustained Responder Status at 24 Weeks of Follow-up
Hide Description The number of participants achieving sustained responder status at 24 weeks of follow-up was assessed. A participant was classified as a sustained responder if, at 24 weeks of follow-up, they met both of the following criteria: 1) HCV-RNA negative (defined as <100 copies/mL serum by qPCR assay); and 2) ALT level normal.
Time Frame Up to 72 weeks (up to 48 weeks treatment and 24 weeks follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all randomized participants receiving ≥1 dose of study treatment.
Arm/Group Title PEG-Intron, 0.5 mg/kg PEG-Intron, 1.0 mg/kg PEG-Intron, 1.5 mg/kg Interferon Alfa-2b
Hide Arm/Group Description:
PEG-Intron administered QW for 48 weeks at 0.5 mg/kg by SC injection.
PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection.
PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection.
Interferon Alfa-2b administered TIW for 48 weeks at 3 MIU by SC injection.
Overall Number of Participants Analyzed 315 297 304 303
Measure Type: Count of Participants
Unit of Measure: Participants
52
  16.5%
70
  23.6%
69
  22.7%
37
  12.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-Intron, 0.5 mg/kg, Interferon Alfa-2b
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.128
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PEG-Intron, 1.0 mg/kg, Interferon Alfa-2b
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PEG-Intron, 1.5 mg/kg, Interferon Alfa-2b
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up)
Adverse Event Reporting Description Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
 
Arm/Group Title PEG-Intron, 0.5 mg/kg PEG-Intron, 1.0 mg/kg PEG-Intron, 1.5 mg/kg Interferon Alfa-2b
Hide Arm/Group Description PEG-Intron administered QW for 48 weeks at 0.5 mg/kg SC injection. PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection. PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection. Interferon Alfa-2b administered TIW for 48 weeks at 3 MIU by SC injection.
All-Cause Mortality
PEG-Intron, 0.5 mg/kg PEG-Intron, 1.0 mg/kg PEG-Intron, 1.5 mg/kg Interferon Alfa-2b
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/315 (0.32%)      0/297 (0.00%)      0/304 (0.00%)      2/303 (0.66%)    
Show Serious Adverse Events Hide Serious Adverse Events
PEG-Intron, 0.5 mg/kg PEG-Intron, 1.0 mg/kg PEG-Intron, 1.5 mg/kg Interferon Alfa-2b
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/315 (11.75%)      32/297 (10.77%)      31/304 (10.20%)      29/303 (9.57%)    
Blood and lymphatic system disorders         
Neutropenia  1  0/315 (0.00%)  0 1/297 (0.34%)  1 1/304 (0.33%)  1 0/303 (0.00%)  0
Thrombocytopenia  1  0/315 (0.00%)  0 2/297 (0.67%)  2 0/304 (0.00%)  0 0/303 (0.00%)  0
Cardiac disorders         
Atrial fibrillation  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Atrial flutter  1  0/315 (0.00%)  0 0/297 (0.00%)  0 1/304 (0.33%)  1 0/303 (0.00%)  0
Cardiomyopathy  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
Cardiopulmonary failure  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Myocardial infarction  1  0/315 (0.00%)  0 0/297 (0.00%)  0 1/304 (0.33%)  1 0/303 (0.00%)  0
Pericarditis  1  0/315 (0.00%)  0 0/297 (0.00%)  0 1/304 (0.33%)  1 0/303 (0.00%)  0
Ear and labyrinth disorders         
Hypoacusis  1  0/315 (0.00%)  0 0/297 (0.00%)  0 1/304 (0.33%)  1 0/303 (0.00%)  0
Sudden hearing loss  1  1/315 (0.32%)  1 0/297 (0.00%)  0 1/304 (0.33%)  1 0/303 (0.00%)  0
Vertigo  1  0/315 (0.00%)  0 0/297 (0.00%)  0 2/304 (0.66%)  2 0/303 (0.00%)  0
Endocrine disorders         
Hyperthyroidism  1  0/315 (0.00%)  0 0/297 (0.00%)  0 1/304 (0.33%)  1 0/303 (0.00%)  0
Eye disorders         
Ophthalmic vein thrombosis  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Retinal exudates  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Retinal tear  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Gastrointestinal disorders         
Abdominal hernia  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Abdominal pain  1  2/315 (0.63%)  2 1/297 (0.34%)  1 0/304 (0.00%)  0 1/303 (0.33%)  1
Abdominal pain upper  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
Appendix disorder  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Haemorrhoids  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
Inguinal hernia  1  1/315 (0.32%)  1 0/297 (0.00%)  0 1/304 (0.33%)  1 0/303 (0.00%)  0
Small intestinal obstruction  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
Vomiting  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
General disorders         
Asthenia  1  0/315 (0.00%)  0 0/297 (0.00%)  0 1/304 (0.33%)  1 0/303 (0.00%)  0
Chest pain  1  2/315 (0.63%)  2 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
Granuloma  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Malaise  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
Hepatobiliary disorders         
Cholelithiasis  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Gallbladder disorder  1  0/315 (0.00%)  0 0/297 (0.00%)  0 1/304 (0.33%)  1 0/303 (0.00%)  0
Immune system disorders         
Anaphylactic reaction  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
Sarcoidosis  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
Infections and infestations         
Abscess  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Abscess limb  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Abscess oral  1  0/315 (0.00%)  0 0/297 (0.00%)  0 1/304 (0.33%)  1 0/303 (0.00%)  0
Appendicitis  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Bronchitis  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 1/303 (0.33%)  1
Diverticulitis  1  0/315 (0.00%)  0 0/297 (0.00%)  0 1/304 (0.33%)  1 0/303 (0.00%)  0
Douglas' abscess  1  0/315 (0.00%)  0 0/297 (0.00%)  0 1/304 (0.33%)  1 0/303 (0.00%)  0
Erysipelas  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Gastroenteritis  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Herpes zoster  1  0/315 (0.00%)  0 0/297 (0.00%)  0 1/304 (0.33%)  1 0/303 (0.00%)  0
Malaria  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Pneumonia  1  0/315 (0.00%)  0 1/297 (0.34%)  1 2/304 (0.66%)  2 0/303 (0.00%)  0
Salmonellosis  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Tonsillitis  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Injury, poisoning and procedural complications         
Femur fracture  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Gun shot wound  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
Hand fracture  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Ligament sprain  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Limb injury  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Overdose  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Pelvic fracture  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Post procedural haemorrhage  1  0/315 (0.00%)  0 0/297 (0.00%)  0 1/304 (0.33%)  1 0/303 (0.00%)  0
Procedural pain  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Subarachnoid haemorrhage  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Toxicity to various agents  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Wrist fracture  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Metabolism and nutrition disorders         
Body fat disorder  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Diabetes mellitus  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
Arthropathy  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Back pain  1  0/315 (0.00%)  0 0/297 (0.00%)  0 1/304 (0.33%)  1 1/303 (0.33%)  1
Intervertebral disc protrusion  1  0/315 (0.00%)  0 2/297 (0.67%)  2 0/304 (0.00%)  0 0/303 (0.00%)  0
Musculoskeletal disorder  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 2/303 (0.66%)  2
Spinal disorder  1  0/315 (0.00%)  0 1/297 (0.34%)  1 2/304 (0.66%)  2 0/303 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma  1  0/315 (0.00%)  0 0/297 (0.00%)  0 1/304 (0.33%)  1 1/303 (0.33%)  1
Breast cancer  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Laryngeal squamous cell carcinoma  1  0/315 (0.00%)  0 0/297 (0.00%)  0 1/304 (0.33%)  1 0/303 (0.00%)  0
Malignant melanoma  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Neoplasm  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
Nervous system neoplasm  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Prostate cancer  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
Skin cancer  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
Nervous system disorders         
Facial paralysis  1  1/315 (0.32%)  1 3/297 (1.01%)  3 0/304 (0.00%)  0 0/303 (0.00%)  0
IIIrd nerve paralysis  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Loss of consciousness  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Migraine  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Presyncope  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
Sciatica  1  0/315 (0.00%)  0 0/297 (0.00%)  0 1/304 (0.33%)  1 0/303 (0.00%)  0
Seizure  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
Somnolence  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Syncope  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Transient ischaemic attack  1  0/315 (0.00%)  0 0/297 (0.00%)  1/304 (0.33%)  1 0/303 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Foetal death  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Psychiatric disorders         
Alcohol abuse  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Anxiety  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Completed suicide  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Dependence  1  0/315 (0.00%)  0 0/297 (0.00%)  0 0/304 (0.00%)  0 1/303 (0.33%)  1
Depression  1  2/315 (0.63%)  2 1/297 (0.34%)  1 1/304 (0.33%)  1 0/303 (0.00%)  0
Depressive symptom  1  0/315 (0.00%)  0 0/297 (0.00%)  0 1/304 (0.33%)  1 1/303 (0.33%)  1
Suicidal ideation  1  3/315 (0.95%)  3 2/297 (0.67%)  2 2/304 (0.66%)  2 1/303 (0.33%)  1
Suicide attempt  1  0/315 (0.00%)  0 0/297 (0.00%)  0 2/304 (0.66%)  2 0/303 (0.00%)  0
Renal and urinary disorders         
Tubulointerstitial nephritis  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Reproductive system and breast disorders         
Breast discharge  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Uterine disorder  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 1/303 (0.33%)  1
Respiratory, thoracic and mediastinal disorders         
Pneumothorax  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dermatosis  1  0/315 (0.00%)  0 0/297 (0.00%)  0 1/304 (0.33%)  1 0/303 (0.00%)  0
Eczema  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Psoriasis  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Rash erythematous  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
Urticaria  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
Surgical and medical procedures         
Cholecystectomy  1  1/315 (0.32%)  1 0/297 (0.00%)  0 0/304 (0.00%)  0 0/303 (0.00%)  0
Vascular disorders         
Hypertension  1  0/315 (0.00%)  0 0/297 (0.00%)  0 2/304 (0.66%)  2 0/303 (0.00%)  0
Varicose vein  1  0/315 (0.00%)  0 1/297 (0.34%)  1 0/304 (0.00%)  0 0/303 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEG-Intron, 0.5 mg/kg PEG-Intron, 1.0 mg/kg PEG-Intron, 1.5 mg/kg Interferon Alfa-2b
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   306/315 (97.14%)      291/297 (97.98%)      296/304 (97.37%)      293/303 (96.70%)    
Blood and lymphatic system disorders         
Neutropenia  1  13/315 (4.13%)  26 18/297 (6.06%)  37 25/304 (8.22%)  36 7/303 (2.31%)  15
Thrombocytopenia  1  7/315 (2.22%)  13 19/297 (6.40%)  37 15/304 (4.93%)  17 1/303 (0.33%)  1
Endocrine disorders         
Hypothyroidism  1  10/315 (3.17%)  12 18/297 (6.06%)  22 15/304 (4.93%)  19 11/303 (3.63%)  13
Gastrointestinal disorders         
Abdominal discomfort  1  12/315 (3.81%)  16 17/297 (5.72%)  20 15/304 (4.93%)  18 15/303 (4.95%)  18
Abdominal pain  1  28/315 (8.89%)  37 24/297 (8.08%)  31 19/304 (6.25%)  20 14/303 (4.62%)  16
Abdominal pain upper  1  48/315 (15.24%)  75 38/297 (12.79%)  51 37/304 (12.17%)  54 33/303 (10.89%)  39
Diarrhoea  1  53/315 (16.83%)  75 58/297 (19.53%)  90 69/304 (22.70%)  103 50/303 (16.50%)  70
Dry mouth  1  11/315 (3.49%)  12 12/297 (4.04%)  13 25/304 (8.22%)  28 12/303 (3.96%)  13
Dyspepsia  1  16/315 (5.08%)  20 11/297 (3.70%)  13 12/304 (3.95%)  20 15/303 (4.95%)  17
Nausea  1  73/315 (23.17%)  114 83/297 (27.95%)  128 83/304 (27.30%)  130 64/303 (21.12%)  95
Vomiting  1  22/315 (6.98%)  29 23/297 (7.74%)  36 23/304 (7.57%)  33 20/303 (6.60%)  22
General disorders         
Asthenia  1  42/315 (13.33%)  89 40/297 (13.47%)  89 50/304 (16.45%)  120 41/303 (13.53%)  63
Chest pain  1  12/315 (3.81%)  14 17/297 (5.72%)  20 7/304 (2.30%)  10 8/303 (2.64%)  8
Chills  1  106/315 (33.65%)  140 120/297 (40.40%)  162 133/304 (43.75%)  184 99/303 (32.67%)  125
Fatigue  1  160/315 (50.79%)  279 164/297 (55.22%)  283 159/304 (52.30%)  287 170/303 (56.11%)  295
Influenza like illness  1  57/315 (18.10%)  74 66/297 (22.22%)  95 76/304 (25.00%)  113 59/303 (19.47%)  78
Injection site erythema  1  135/315 (42.86%)  189 120/297 (40.40%)  166 122/304 (40.13%)  164 47/303 (15.51%)  49
Malaise  1  20/315 (6.35%)  41 27/297 (9.09%)  43 24/304 (7.89%)  86 21/303 (6.93%)  28
Pain  1  55/315 (17.46%)  89 61/297 (20.54%)  87 60/304 (19.74%)  90 50/303 (16.50%)  64
Pyrexia  1  96/315 (30.48%)  141 124/297 (41.75%)  191 127/304 (41.78%)  206 86/303 (28.38%)  106
Hepatobiliary disorders         
Hepatomegaly  1  20/315 (6.35%)  22 16/297 (5.39%)  17 16/304 (5.26%)  18 10/303 (3.30%)  12
Liver tenderness  1  12/315 (3.81%)  12 10/297 (3.37%)  12 16/304 (5.26%)  17 9/303 (2.97%)  10
Infections and infestations         
Bronchitis  1  15/315 (4.76%)  24 18/297 (6.06%)  19 13/304 (4.28%)  19 10/303 (3.30%)  12
Influenza  1  17/315 (5.40%)  21 19/297 (6.40%)  22 20/304 (6.58%)  23 22/303 (7.26%)  29
Nasopharyngitis  1  36/315 (11.43%)  45 21/297 (7.07%)  31 27/304 (8.88%)  33 24/303 (7.92%)  30
Sinusitis  1  26/315 (8.25%)  33 21/297 (7.07%)  22 27/304 (8.88%)  37 19/303 (6.27%)  29
Upper respiratory tract infection  1  20/315 (6.35%)  23 12/297 (4.04%)  14 9/304 (2.96%)  10 14/303 (4.62%)  22
Investigations         
Weight decreased  1  34/315 (10.79%)  45 36/297 (12.12%)  45 74/304 (24.34%)  91 42/303 (13.86%)  46
Metabolism and nutrition disorders         
Decreased appetite  1  33/315 (10.48%)  39 59/297 (19.87%)  72 76/304 (25.00%)  86 49/303 (16.17%)  60
Musculoskeletal and connective tissue disorders         
Arthralgia  1  78/315 (24.76%)  145 71/297 (23.91%)  116 86/304 (28.29%)  159 73/303 (24.09%)  124
Back pain  1  46/315 (14.60%)  58 57/297 (19.19%)  81 48/304 (15.79%)  78 56/303 (18.48%)  89
Muscle spasms  1  25/315 (7.94%)  34 15/297 (5.05%)  21 11/304 (3.62%)  15 12/303 (3.96%)  21
Musculoskeletal pain  1  10/315 (3.17%)  14 17/297 (5.72%)  24 8/304 (2.63%)  10 12/303 (3.96%)  13
Myalgia  1  111/315 (35.24%)  212 107/297 (36.03%)  178 135/304 (44.41%)  249 114/303 (37.62%)  187
Pain in extremity  1  20/315 (6.35%)  31 31/297 (10.44%)  45 22/304 (7.24%)  34 20/303 (6.60%)  22
Nervous system disorders         
Disturbance in attention  1  20/315 (6.35%)  27 22/297 (7.41%)  29 21/304 (6.91%)  23 16/303 (5.28%)  19
Dizziness  1  29/315 (9.21%)  34 38/297 (12.79%)  43 45/304 (14.80%)  58 34/303 (11.22%)  51
Headache  1  192/315 (60.95%)  445 200/297 (67.34%)  481 195/304 (64.14%)  492 177/303 (58.42%)  351
Psychiatric disorders         
Anxiety  1  32/315 (10.16%)  59 30/297 (10.10%)  51 25/304 (8.22%)  34 33/303 (10.89%)  53
Depression  1  73/315 (23.17%)  135 72/297 (24.24%)  114 74/304 (24.34%)  116 66/303 (21.78%)  112
Insomnia  1  51/315 (16.19%)  73 74/297 (24.92%)  101 58/304 (19.08%)  82 64/303 (21.12%)  105
Irritability  1  65/315 (20.63%)  92 53/297 (17.85%)  76 57/304 (18.75%)  84 74/303 (24.42%)  106
Libido decreased  1  9/315 (2.86%)  9 6/297 (2.02%)  7 10/304 (3.29%)  13 17/303 (5.61%)  19
Nervousness  1  14/315 (4.44%)  20 15/297 (5.05%)  22 10/304 (3.29%)  15 6/303 (1.98%)  7
Respiratory, thoracic and mediastinal disorders         
Cough  1  23/315 (7.30%)  28 25/297 (8.42%)  27 30/304 (9.87%)  36 16/303 (5.28%)  18
Dyspnoea  1  18/315 (5.71%)  25 12/297 (4.04%)  14 15/304 (4.93%)  15 3/303 (0.99%)  3
Oropharyngeal pain  1  17/315 (5.40%)  19 17/297 (5.72%)  20 16/304 (5.26%)  18 16/303 (5.28%)  22
Skin and subcutaneous tissue disorders         
Alopecia  1  64/315 (20.32%)  75 68/297 (22.90%)  82 104/304 (34.21%)  113 67/303 (22.11%)  78
Dry skin  1  18/315 (5.71%)  23 33/297 (11.11%)  38 29/304 (9.54%)  33 27/303 (8.91%)  30
Hyperhidrosis  1  16/315 (5.08%)  21 13/297 (4.38%)  14 17/304 (5.59%)  23 13/303 (4.29%)  16
Pruritus  1  30/315 (9.52%)  38 37/297 (12.46%)  45 28/304 (9.21%)  30 22/303 (7.26%)  28
Rash  1  22/315 (6.98%)  27 21/297 (7.07%)  24 24/304 (7.89%)  27 18/303 (5.94%)  19
Vascular disorders         
Hot flush  1  8/315 (2.54%)  9 16/297 (5.39%)  17 7/304 (2.30%)  8 6/303 (1.98%)  7
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Adverse Event (AE) Preferred Terms were converted from WHO-ART dictionary to the MedDRA version 21.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigator agrees to provide the Sponsor thirty (30) days prior to submission for publication or presentation, copies of abstracts or manuscripts for publication which report project results. The Sponsor shall have editorial rights with respect to Publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation with regard to (a) proprietary information and, (b) the accuracy of the information contained in the Publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03537274     History of Changes
Other Study ID Numbers: C97010
MK-4031-016 ( Other Identifier: Merck Protocol Number )
C97010 ( Other Identifier: Schering-Plough Protocol Number )
First Submitted: May 15, 2018
First Posted: May 25, 2018
Results First Submitted: January 10, 2019
Results First Posted: April 9, 2019
Last Update Posted: April 9, 2019