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Trial record 2 of 295 for:    IFNA2 AND PEG-interferon alfa-2b

Polyethylene Glycol Interferon Alfa-2b (PEG Intron) Versus Interferon Alfa-2b (INTRON^® A) in the Treatment of Newly Diagnosed Chronic Myelogenous Leukemia (CML) (C98026)

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ClinicalTrials.gov Identifier: NCT03547154
Recruitment Status : Terminated
First Posted : June 6, 2018
Results First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Myelogenous Leukemia
Interventions Biological: Pegylated interferon alfa-2b
Biological: Interferon alfa-2b
Enrollment 344
Recruitment Details  
Pre-assignment Details  
Arm/Group Title INTRON A (Interferon Alfa-2b) PEG Intron (Pegylated Interferon Alfa-2b)
Hide Arm/Group Description Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m^2, administered daily by SC injection. Treatment was for a minimum of 6 months (mo.) unless there was evidence of disease progression or unacceptable toxicity. Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 173 171
Completed 50 55
Not Completed 123 116
Reason Not Completed
Disease Progression/Recurrence             6             14
Adverse Event             26             31
Protocol Violation             6             1
Physician Decision             4             3
Insufficient Therapeutic Response             13             10
Withdrawal by Subject             10             6
Not Selected             0             1
Continued treatment beyond 12 mo.             58             50
Arm/Group Title INTRON A (Interferon Alfa-2b) PEG Intron (Pegylated Interferon Alfa-2b) Total
Hide Arm/Group Description Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m^2, administered daily by SC injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity. Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 173 171 344
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 173 participants 171 participants 344 participants
51.6  (13.4) 51.9  (12.8) 51.7  (13.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 173 participants 171 participants 344 participants
Female
67
  38.7%
75
  43.9%
142
  41.3%
Male
106
  61.3%
96
  56.1%
202
  58.7%
1.Primary Outcome
Title Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months
Hide Description Cytogenetic response (CR) was defined by the degree of suppression of Philadelphia chromosome (Ph^1) achieved during study treatment. For all participants continuing treatment after study conclusion, cytogenetic assessments were conducted locally as per standard of care. Determination of CR at 12 months were based on cytogenetic analysis of bone marrow aspirate samples. The CR criteria were based on the percentage (%) of PH^1-positive cells during study treatment. Protocol-defined CR criteria were Complete Response (0%), Partial Response (1-34%), Minor Response (35-90%), or No Response (>90%). Data for the analysis population was based on the intent-to-treat principle. Participants who were treatment failures at 6 months were considered cytogenetic non-responders. Recording of CR was independent of hematologic responses.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants analyzed on an intent-to-treat basis.
Arm/Group Title INTRON A (Interferon Alfa-2b) PEG Intron (Pegylated Interferon Alfa-2b)
Hide Arm/Group Description:
Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m^2, administered daily by SC injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 173 171
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
13
   7.5%
13
   7.6%
Partial Response
35
  20.2%
26
  15.2%
Minor Respnse
31
  17.9%
24
  14.0%
No Respnse
15
   8.7%
25
  14.6%
Discontinued or No Hematologic CR at Month 6
78
  45.1%
83
  48.5%
Participants with Missing Data
1
   0.6%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INTRON A (Interferon Alfa-2b), PEG Intron (Pegylated Interferon Alfa-2b)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.322
Comments Analysis of Major Response
Method Fisher Exact
Comments Missing data considered failures
2.Secondary Outcome
Title Number of Participants With Cytogenetic Response (CR) to PEG Intron and Intron A at 6 Months
Hide Description Cytogenetic response (CR) at 6 months, as at 12 months, was defined by the degree of suppression of Philadelphia chromosome (Ph^1) achieved during study treatment. The determination of CR at 6 months was based on cytogenetic analysis of bone marrow aspirate samples. The CR criteria were based on the percentage (%) of PH^1-positive cells during study treatment. Protocol-defined CR criteria were Complete (0%), Partial (1-34%), Minor (35-90%), or No Response (>90%). Data for the analysis population was based on the intent-to-treat principle. Participants who were treatment failures at 6 months were considered cytogenetic non-responders. Recording of CR was independent of hematologic responses.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of assigned treatment
Arm/Group Title INTRON A (Interferon Alfa-2b) PEG Intron (Pegylated Interferon Alfa-2b)
Hide Arm/Group Description:
Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m^2, administered daily by SC injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 173 171
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response: 0% Ph+
7
   4.0%
3
   1.8%
Partial Response: 1-34% Ph+
19
  11.0%
23
  13.5%
Minor Response: 35-90% Ph+
51
  29.5%
37
  21.6%
No Response: >90% Ph+
48
  27.7%
61
  35.7%
Participant with Missing Data
48
  27.7%
47
  27.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INTRON A (Interferon Alfa-2b), PEG Intron (Pegylated Interferon Alfa-2b)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.999
Comments Analysis of Major Response
Method Fisher Exact
Comments Missing data considered failures
3.Secondary Outcome
Title Number of Participants With Hematologic Responses to PEG Intron and Intron A at 6 Months
Hide Description Hematologic response at 6 months was assessed, while the hematologic response was measured at 3, 6, 9 and 12 months during the first year of study treatment. To be considered a hematologic responder a participant must have met all of the following criteria for a minimum of 28 days: WBC count <10,000/μL; platelet count <450,000/L; normal differential count in peripheral blood (manual differential count); no palpable spleen. Participants achieving a complete hematologic response at 3 months had the cytogenetic response evaluated at 3 months as well. Participants who achieved a complete hematologic response by 6 months continued treatment for another 6 months. Participants who failed to achieve a complete hematologic response after 6 months of treatment were considered treatment failures, and further treatment for this group was at the discretion of the treating physician. Participants may have continued to receive their assigned study medication for an additional 6 months.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of assigned treatment
Arm/Group Title INTRON A (Interferon Alfa-2b) PEG Intron (Pegylated Interferon Alfa-2b)
Hide Arm/Group Description:
Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m^2, administered daily by SC injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 173 171
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
98
  56.6%
91
  53.2%
Treatment Failure
44
  25.4%
52
  30.4%
Missing
31
  17.9%
28
  16.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INTRON A (Interferon Alfa-2b), PEG Intron (Pegylated Interferon Alfa-2b)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.588
Comments Analysis of Complete Response
Method Fisher Exact
Comments Missing data considered failures
4.Secondary Outcome
Title Number of Participants With Overall Survival
Hide Description Participants were followed for survival; those who did not achieve a major cytogenetic response were discontinued from the study. For participants who completed 1 year of study treatment and continued to Year 2 and beyond, survival and disease progression every 3 months were assessed, and serious adverse events (SAEs) were reported. Participants were followed until resolution of any drug-related nonserious adverse event, and any SAE occurring while on the study or within 30 days of last dose of study drug. Participant death during survival follow-up was reported to the drug safety unit of the Sponsor. Each participant (whether discontinued or still on treatment) was followed every 3 months for survival and disease progression information. Overall survival was analyzed using the log-rank statistic, and the hazard ratio (HR) and 95% confidence interval (CI) for the HR were obtained using Cox's proportional hazards model.
Time Frame Up to 2 years (24 months), and beyond
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of assigned treatment
Arm/Group Title INTRON A (Interferon Alfa-2b) PEG Intron (Pegylated Interferon Alfa-2b)
Hide Arm/Group Description:
Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m^2, administered daily by SC injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 173 171
Measure Type: Count of Participants
Unit of Measure: Participants
Deaths
15
   8.7%
17
   9.9%
Survivors
158
  91.3%
154
  90.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INTRON A (Interferon Alfa-2b), PEG Intron (Pegylated Interferon Alfa-2b)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.859
Confidence Interval (2-Sided) 95%
0.429 to 1.721
Estimation Comments Overall survival was analyzed using the log-rank statistic. The HR and 95% CI for the HR were obtained using Cox’s proportional hazards model.
Time Frame Up to One Year
Adverse Event Reporting Description An AE is any physical or clinical change or disease experienced by the participant at any time during the course of the study, whether or not considered related to the use of the study drug. This includes the onset of new illness and the exacerbation of pre-existing conditions other than the indication under study. The population analyzed was all randomized participants who received at least one dose of study treatment. One randomized participant died before receiving treatment.
 
Arm/Group Title INTRON A, 5 MIU/m^2 Daily PEG-Intron, 6.0 mcg/kg Weekly
Hide Arm/Group Description Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m^2, administered daily by SC injection. Treatment was for a minimum of 6 months (mo.) unless there was evidence of disease progression or unacceptable toxicity. Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity.
All-Cause Mortality
INTRON A, 5 MIU/m^2 Daily PEG-Intron, 6.0 mcg/kg Weekly
Affected / at Risk (%) Affected / at Risk (%)
Total   15/173 (8.67%)      17/171 (9.94%)    
Show Serious Adverse Events Hide Serious Adverse Events
INTRON A, 5 MIU/m^2 Daily PEG-Intron, 6.0 mcg/kg Weekly
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   62/173 (35.84%)      74/171 (43.27%)    
Blood and lymphatic system disorders     
ANAEMIA  1  0/173 (0.00%)  0 4/171 (2.34%)  4
HAEMOLYTIC ANAEMIA  1  1/173 (0.58%)  1 0/171 (0.00%)  0
HYPERGAMMAGLOBULINAEMIA  1  1/173 (0.58%)  1 0/171 (0.00%)  0
LEUKOPENIA  1  1/173 (0.58%)  1 0/171 (0.00%)  0
LYMPHADENOPATHY  1  0/173 (0.00%)  0 1/171 (0.58%)  1
NEUTROPENIA  1  3/173 (1.73%)  3 1/171 (0.58%)  1
THROMBOCYTOPENIA  1  4/173 (2.31%)  4 3/171 (1.75%)  3
Cardiac disorders     
ANGINA PECTORIS  1  1/173 (0.58%)  1 0/171 (0.00%)  0
ATRIAL FIBRILLATION  1  1/173 (0.58%)  1 1/171 (0.58%)  1
BRADYCARDIA  1  0/173 (0.00%)  0 1/171 (0.58%)  1
CARDIAC FAILURE CONGESTIVE  1  1/173 (0.58%)  1 0/171 (0.00%)  0
CYANOSIS  1  1/173 (0.58%)  1 0/171 (0.00%)  0
MYOCARDIAL INFARCTION  1  0/173 (0.00%)  0 1/171 (0.58%)  1
PALPITATIONS  1  1/173 (0.58%)  1 0/171 (0.00%)  0
TACHYARRHYTHMIA  1  0/173 (0.00%)  0 1/171 (0.58%)  1
Ear and labyrinth disorders     
VERTIGO  1  1/173 (0.58%)  1 2/171 (1.17%)  2
Endocrine disorders     
HYPERTHYROIDISM  1  0/173 (0.00%)  0 1/171 (0.58%)  1
HYPOTHYROIDISM  1  0/173 (0.00%)  0 1/171 (0.58%)  1
Eye disorders     
OCULAR TOXICITY  1  0/173 (0.00%)  0 1/171 (0.58%)  1
VISUAL ACUITY REDUCED  1  0/173 (0.00%)  0 1/171 (0.58%)  1
Gastrointestinal disorders     
ABDOMINAL PAIN  1  2/173 (1.16%)  3 3/171 (1.75%)  3
ABDOMINAL PAIN UPPER  1  1/173 (0.58%)  1 0/171 (0.00%)  0
DIARRHOEA  1  1/173 (0.58%)  1 2/171 (1.17%)  2
DUODENAL ULCER  1  0/173 (0.00%)  0 1/171 (0.58%)  1
DUODENITIS  1  0/173 (0.00%)  0 1/171 (0.58%)  1
DYSPHAGIA  1  1/173 (0.58%)  1 0/171 (0.00%)  0
GASTRITIS  1  0/173 (0.00%)  0 1/171 (0.58%)  1
GASTROINTESTINAL HAEMORRHAGE  1  0/173 (0.00%)  0 1/171 (0.58%)  1
HIATUS HERNIA  1  1/173 (0.58%)  1 1/171 (0.58%)  1
INGUINAL HERNIA  1  2/173 (1.16%)  2 0/171 (0.00%)  0
MOUTH ULCERATION  1  0/173 (0.00%)  0 1/171 (0.58%)  1
NAUSEA  1  3/173 (1.73%)  4 6/171 (3.51%)  6
PANCREATITIS ACUTE  1  0/173 (0.00%)  0 1/171 (0.58%)  1
VOMITING  1  4/173 (2.31%)  5 3/171 (1.75%)  3
General disorders     
ASTHENIA  1  2/173 (1.16%)  4 2/171 (1.17%)  2
CHEST PAIN  1  3/173 (1.73%)  5 5/171 (2.92%)  5
CHILLS  1  2/173 (1.16%)  3 2/171 (1.17%)  2
FATIGUE  1  0/173 (0.00%)  0 3/171 (1.75%)  3
HERNIA  1  0/173 (0.00%)  0 1/171 (0.58%)  1
HYPERTHERMIA  1  1/173 (0.58%)  1 0/171 (0.00%)  0
HYPOTHERMIA  1  0/173 (0.00%)  0 1/171 (0.58%)  1
MALAISE  1  0/173 (0.00%)  0 1/171 (0.58%)  1
PYREXIA  1  6/173 (3.47%)  8 7/171 (4.09%)  8
Hepatobiliary disorders     
CHOLECYSTITIS ACUTE  1  1/173 (0.58%)  1 0/171 (0.00%)  0
CHOLELITHIASIS  1  2/173 (1.16%)  2 0/171 (0.00%)  0
CYTOLYTIC HEPATITIS  1  0/173 (0.00%)  0 1/171 (0.58%)  1
HEPATOMEGALY  1  0/173 (0.00%)  0 2/171 (1.17%)  2
HEPATOTOXICITY  1  0/173 (0.00%)  0 1/171 (0.58%)  1
JAUNDICE  1  1/173 (0.58%)  2 0/171 (0.00%)  0
Infections and infestations     
APPENDICITIS  1  2/173 (1.16%)  2 1/171 (0.58%)  1
BRONCHOPNEUMONIA  1  1/173 (0.58%)  1 0/171 (0.00%)  0
CELLULITIS  1  0/173 (0.00%)  0 1/171 (0.58%)  1
FUNGAL INFECTION  1  1/173 (0.58%)  1 0/171 (0.00%)  0
GASTROENTERITIS  1  0/173 (0.00%)  0 1/171 (0.58%)  1
HERPES ZOSTER  1  1/173 (0.58%)  1 0/171 (0.00%)  0
INFECTED CYST  1  1/173 (0.58%)  1 0/171 (0.00%)  0
INFECTION  1  0/173 (0.00%)  0 2/171 (1.17%)  2
INJECTION SITE ABSCESS  1  2/173 (1.16%)  2 0/171 (0.00%)  0
LOWER RESPIRATORY TRACT INFECTION  1  1/173 (0.58%)  1 1/171 (0.58%)  1
NEUTROPENIC SEPSIS  1  1/173 (0.58%)  1 0/171 (0.00%)  0
PHARYNGITIS  1  0/173 (0.00%)  0 1/171 (0.58%)  1
PNEUMONIA  1  3/173 (1.73%)  3 2/171 (1.17%)  2
RESPIRATORY TRACT INFECTION  1  1/173 (0.58%)  1 0/171 (0.00%)  0
SEPSIS  1  1/173 (0.58%)  1 0/171 (0.00%)  0
STAPHYLOCOCCAL ABSCESS  1  0/173 (0.00%)  0 1/171 (0.58%)  1
URINARY TRACT INFECTION  1  1/173 (0.58%)  1 0/171 (0.00%)  0
UROSEPSIS  1  0/173 (0.00%)  0 1/171 (0.58%)  1
Injury, poisoning and procedural complications     
JOINT DISLOCATION  1  0/173 (0.00%)  0 1/171 (0.58%)  1
JOINT INJURY  1  1/173 (0.58%)  1 0/171 (0.00%)  0
OVERDOSE  1  0/173 (0.00%)  0 2/171 (1.17%)  2
Investigations     
ALANINE AMINOTRANSFERASE ABNORMAL  1  1/173 (0.58%)  1 0/171 (0.00%)  0
ALANINE AMINOTRANSFERASE INCREASED  1  2/173 (1.16%)  2 2/171 (1.17%)  6
ASPARTATE AMINOTRANSFERASE INCREASED  1  1/173 (0.58%)  1 2/171 (1.17%)  5
BLOOD BILIRUBIN INCREASED  1  1/173 (0.58%)  1 0/171 (0.00%)  0
BODY TEMPERATURE INCREASED  1  0/173 (0.00%)  0 1/171 (0.58%)  1
HEPATIC ENZYME INCREASED  1  2/173 (1.16%)  3 2/171 (1.17%)  2
HEPATITIS B VIRUS  1  0/173 (0.00%)  0 1/171 (0.58%)  1
LABORATORY TEST ABNORMAL  1  1/173 (0.58%)  1 0/171 (0.00%)  0
TRANSAMINASES INCREASED  1  2/173 (1.16%)  2 1/171 (0.58%)  1
WEIGHT DECREASED  1  1/173 (0.58%)  1 2/171 (1.17%)  2
Metabolism and nutrition disorders     
ANOREXIA  1  2/173 (1.16%)  3 1/171 (0.58%)  1
CELL DEATH  1  1/173 (0.58%)  2 0/171 (0.00%)  0
DEHYDRATION  1  2/173 (1.16%)  2 1/171 (0.58%)  1
HYPERCALCAEMIA  1  1/173 (0.58%)  1 0/171 (0.00%)  0
HYPOGLYCAEMIA  1  2/173 (1.16%)  2 0/171 (0.00%)  0
HYPOVOLAEMIA  1  0/173 (0.00%)  0 1/171 (0.58%)  1
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  3/173 (1.73%)  3 7/171 (4.09%)  7
BACK PAIN  1  2/173 (1.16%)  2 1/171 (0.58%)  1
BONE PAIN  1  2/173 (1.16%)  2 1/171 (0.58%)  1
INTERVERTEBRAL DISC PROTRUSION  1  0/173 (0.00%)  0 1/171 (0.58%)  1
MUSCULOSKELETAL CHEST PAIN  1  1/173 (0.58%)  3 1/171 (0.58%)  1
MUSCULOSKELETAL PAIN  1  1/173 (0.58%)  1 0/171 (0.00%)  0
MYALGIA  1  2/173 (1.16%)  2 0/171 (0.00%)  0
NECK PAIN  1  0/173 (0.00%)  0 1/171 (0.58%)  1
OSTEONECROSIS  1  0/173 (0.00%)  0 2/171 (1.17%)  2
PAIN IN EXTREMITY  1  1/173 (0.58%)  1 5/171 (2.92%)  5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
BLAST CELL CRISIS  1  0/173 (0.00%)  0 2/171 (1.17%)  2
BLAST CRISIS IN MYELOGENOUS LEUKAEMIA  1  0/173 (0.00%)  0 1/171 (0.58%)  1
LYMPHOMA  1  0/173 (0.00%)  0 1/171 (0.58%)  1
NON-HODGKIN'S LYMPHOMA  1  1/173 (0.58%)  1 0/171 (0.00%)  0
THYROID NEOPLASM  1  0/173 (0.00%)  0 1/171 (0.58%)  1
Nervous system disorders     
CEREBRAL HAEMORRHAGE  1  1/173 (0.58%)  1 0/171 (0.00%)  0
CEREBRAL ISCHAEMIA  1  0/173 (0.00%)  0 1/171 (0.58%)  1
CEREBROVASCULAR ACCIDENT  1  1/173 (0.58%)  1 1/171 (0.58%)  1
COMA  1  1/173 (0.58%)  1 0/171 (0.00%)  0
CONVULSION  1  1/173 (0.58%)  1 0/171 (0.00%)  0
DIZZINESS  1  2/173 (1.16%)  2 4/171 (2.34%)  5
EPILEPSY  1  0/173 (0.00%)  0 3/171 (1.75%)  3
GRAND MAL CONVULSION  1  0/173 (0.00%)  0 1/171 (0.58%)  1
HEADACHE  1  0/173 (0.00%)  0 2/171 (1.17%)  2
LOSS OF CONSCIOUSNESS  1  1/173 (0.58%)  1 2/171 (1.17%)  2
NEUROPATHY PERIPHERAL  1  0/173 (0.00%)  0 1/171 (0.58%)  1
PARAESTHESIA  1  0/173 (0.00%)  0 1/171 (0.58%)  1
PARESIS  1  1/173 (0.58%)  1 0/171 (0.00%)  0
SCIATICA  1  1/173 (0.58%)  1 2/171 (1.17%)  2
SOMNOLENCE  1  1/173 (0.58%)  1 0/171 (0.00%)  0
STATUS EPILEPTICUS  1  0/173 (0.00%)  0 1/171 (0.58%)  1
SYNCOPE  1  1/173 (0.58%)  1 2/171 (1.17%)  2
SYNCOPE VASOVAGAL  1  2/173 (1.16%)  2 2/171 (1.17%)  2
TRANSIENT ISCHAEMIC ATTACK  1  1/173 (0.58%)  1 1/171 (0.58%)  1
Psychiatric disorders     
ANXIETY  1  0/173 (0.00%)  0 1/171 (0.58%)  1
COMPLETED SUICIDE  1  1/173 (0.58%)  1 0/171 (0.00%)  0
CONFUSIONAL STATE  1  2/173 (1.16%)  2 1/171 (0.58%)  1
DEPRESSION  1  3/173 (1.73%)  3 3/171 (1.75%)  3
INSOMNIA  1  0/173 (0.00%)  0 1/171 (0.58%)  1
MENTAL STATUS CHANGES  1  0/173 (0.00%)  0 1/171 (0.58%)  1
SUICIDAL IDEATION  1  1/173 (0.58%)  1 0/171 (0.00%)  0
Renal and urinary disorders     
URINARY INCONTINENCE  1  0/173 (0.00%)  0 2/171 (1.17%)  2
Reproductive system and breast disorders     
CYSTOCELE  1  0/173 (0.00%)  0 1/171 (0.58%)  1
METRORRHAGIA  1  0/173 (0.00%)  0 1/171 (0.58%)  1
Respiratory, thoracic and mediastinal disorders     
COUGH  1  1/173 (0.58%)  1 0/171 (0.00%)  0
DYSPNOEA  1  3/173 (1.73%)  3 4/171 (2.34%)  5
EPISTAXIS  1  1/173 (0.58%)  1 0/171 (0.00%)  0
PLEURISY  1  1/173 (0.58%)  1 0/171 (0.00%)  0
PULMONARY EMBOLISM  1  0/173 (0.00%)  0 1/171 (0.58%)  1
Skin and subcutaneous tissue disorders     
ECZEMA  1  0/173 (0.00%)  0 1/171 (0.58%)  1
PRURITUS  1  1/173 (0.58%)  1 1/171 (0.58%)  1
PSORIASIS  1  1/173 (0.58%)  1 0/171 (0.00%)  0
RASH  1  1/173 (0.58%)  1 0/171 (0.00%)  0
RASH ERYTHEMATOUS  1  1/173 (0.58%)  1 1/171 (0.58%)  1
RASH MACULO-PAPULAR  1  0/173 (0.00%)  0 1/171 (0.58%)  1
Vascular disorders     
AORTIC ANEURYSM  1  2/173 (1.16%)  2 0/171 (0.00%)  0
CIRCULATORY COLLAPSE  1  0/173 (0.00%)  0 1/171 (0.58%)  1
HYPOTENSION  1  0/173 (0.00%)  0 2/171 (1.17%)  2
VENA CAVA THROMBOSIS  1  0/173 (0.00%)  0 1/171 (0.58%)  1
1
Term from vocabulary, MedDRA 10.0
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%
INTRON A, 5 MIU/m^2 Daily PEG-Intron, 6.0 mcg/kg Weekly
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   170/173 (98.27%)      168/171 (98.25%)    
Blood and lymphatic system disorders     
ANAEMIA  1  8/173 (4.62%)  10 21/171 (12.28%)  43
LEUKOPENIA  1  19/173 (10.98%)  32 19/171 (11.11%)  38
LYMPHADENOPATHY  1  6/173 (3.47%)  7 13/171 (7.60%)  13
NEUTROPENIA  1  9/173 (5.20%)  11 12/171 (7.02%)  29
THROMBOCYTOPENIA  1  35/173 (20.23%)  65 34/171 (19.88%)  74
Cardiac disorders     
PALPITATIONS  1  3/173 (1.73%)  3 10/171 (5.85%)  18
Ear and labyrinth disorders     
EAR PAIN  1  7/173 (4.05%)  63 10/171 (5.85%)  17
TINNITUS  1  6/173 (3.47%)  9 11/171 (6.43%)  17
VERTIGO  1  22/173 (12.72%)  36 23/171 (13.45%)  61
Eye disorders     
CONJUNCTIVITIS  1  6/173 (3.47%)  6 10/171 (5.85%)  15
EYE PAIN  1  12/173 (6.94%)  42 8/171 (4.68%)  25
VISION BLURRED  1  11/173 (6.36%)  14 13/171 (7.60%)  16
Gastrointestinal disorders     
ABDOMINAL PAIN  1  33/173 (19.08%)  59 39/171 (22.81%)  105
ABDOMINAL PAIN UPPER  1  44/173 (25.43%)  108 51/171 (29.82%)  169
APHTHOUS STOMATITIS  1  10/173 (5.78%)  15 7/171 (4.09%)  8
CONSTIPATION  1  38/173 (21.97%)  130 36/171 (21.05%)  89
DIARRHOEA  1  95/173 (54.91%)  314 104/171 (60.82%)  503
DRY MOUTH  1  61/173 (35.26%)  157 57/171 (33.33%)  179
DYSPEPSIA  1  23/173 (13.29%)  28 18/171 (10.53%)  33
GASTRITIS  1  9/173 (5.20%)  14 3/171 (1.75%)  3
GINGIVAL BLEEDING  1  2/173 (1.16%)  2 10/171 (5.85%)  14
NAUSEA  1  101/173 (58.38%)  429 111/171 (64.91%)  627
ORAL PAIN  1  2/173 (1.16%)  3 12/171 (7.02%)  38
STOMACH DISCOMFORT  1  16/173 (9.25%)  86 13/171 (7.60%)  51
STOMATITIS  1  13/173 (7.51%)  16 9/171 (5.26%)  17
TOOTHACHE  1  8/173 (4.62%)  11 9/171 (5.26%)  11
VOMITING  1  53/173 (30.64%)  108 62/171 (36.26%)  178
General disorders     
ASTHENIA  1  81/173 (46.82%)  246 94/171 (54.97%)  400
CHEST PAIN  1  26/173 (15.03%)  68 26/171 (15.20%)  75
CHILLS  1  108/173 (62.43%)  254 115/171 (67.25%)  377
FATIGUE  1  105/173 (60.69%)  637 103/171 (60.23%)  929
FEELING COLD  1  9/173 (5.20%)  12 6/171 (3.51%)  24
GAIT DISTURBANCE  1  7/173 (4.05%)  7 12/171 (7.02%)  25
INFLUENZA LIKE ILLNESS  1  7/173 (4.05%)  10 10/171 (5.85%)  22
INJECTION SITE ERYTHEMA  1  17/173 (9.83%)  19 37/171 (21.64%)  80
INJECTION SITE PAIN  1  19/173 (10.98%)  31 20/171 (11.70%)  35
INJECTION SITE RASH  1  5/173 (2.89%)  7 11/171 (6.43%)  18
INJECTION SITE REACTION  1  6/173 (3.47%)  7 18/171 (10.53%)  48
IRRITABILITY  1  14/173 (8.09%)  34 9/171 (5.26%)  18
MALAISE  1  19/173 (10.98%)  45 27/171 (15.79%)  180
OEDEMA PERIPHERAL  1  11/173 (6.36%)  13 18/171 (10.53%)  28
PAIN  1  49/173 (28.32%)  135 48/171 (28.07%)  236
PYREXIA  1  133/173 (76.88%)  468 141/171 (82.46%)  1121
THIRST  1  4/173 (2.31%)  5 12/171 (7.02%)  16
Infections and infestations     
BRONCHITIS  1  13/173 (7.51%)  20 19/171 (11.11%)  25
NASOPHARYNGITIS  1  18/173 (10.40%)  21 24/171 (14.04%)  56
ORAL HERPES  1  5/173 (2.89%)  5 11/171 (6.43%)  17
PHARYNGITIS  1  6/173 (3.47%)  9 10/171 (5.85%)  12
RHINITIS  1  9/173 (5.20%)  9 9/171 (5.26%)  13
SINUSITIS  1  10/173 (5.78%)  12 9/171 (5.26%)  17
UPPER RESPIRATORY TRACT INFECTION  1  10/173 (5.78%)  12 13/171 (7.60%)  17
URINARY TRACT INFECTION  1  8/173 (4.62%)  10 15/171 (8.77%)  18
Investigations     
PLATELET COUNT DECREASED  1  11/173 (6.36%)  15 11/171 (6.43%)  19
WEIGHT DECREASED  1  69/173 (39.88%)  128 81/171 (47.37%)  122
WHITE BLOOD CELL COUNT DECREASED  1  11/173 (6.36%)  19 12/171 (7.02%)  39
Metabolism and nutrition disorders     
ANOREXIA  1  86/173 (49.71%)  218 103/171 (60.23%)  315
DECREASED APPETITE  1  24/173 (13.87%)  52 29/171 (16.96%)  63
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  79/173 (45.66%)  401 87/171 (50.88%)  474
BACK PAIN  1  82/173 (47.40%)  337 80/171 (46.78%)  472
BONE PAIN  1  24/173 (13.87%)  93 48/171 (28.07%)  292
FLANK PAIN  1  9/173 (5.20%)  30 7/171 (4.09%)  10
MUSCLE SPASMS  1  21/173 (12.14%)  54 14/171 (8.19%)  69
MUSCULAR WEAKNESS  1  16/173 (9.25%)  25 17/171 (9.94%)  36
MUSCULOSKELETAL CHEST PAIN  1  14/173 (8.09%)  34 16/171 (9.36%)  20
MUSCULOSKELETAL PAIN  1  38/173 (21.97%)  89 33/171 (19.30%)  65
MUSCULOSKELETAL STIFFNESS  1  8/173 (4.62%)  14 16/171 (9.36%)  51
MYALGIA  1  109/173 (63.01%)  416 99/171 (57.89%)  532
NECK PAIN  1  16/173 (9.25%)  28 17/171 (9.94%)  51
PAIN IN EXTREMITY  1  64/173 (36.99%)  304 56/171 (32.75%)  187
Nervous system disorders     
AGEUSIA  1  4/173 (2.31%)  5 10/171 (5.85%)  19
AMNESIA  1  10/173 (5.78%)  18 6/171 (3.51%)  10
DISTURBANCE IN ATTENTION  1  12/173 (6.94%)  27 9/171 (5.26%)  15
DIZZINESS  1  68/173 (39.31%)  256 59/171 (34.50%)  252
DYSGEUSIA  1  34/173 (19.65%)  75 35/171 (20.47%)  101
HEADACHE  1  128/173 (73.99%)  716 132/171 (77.19%)  1362
HYPOAESTHESIA  1  14/173 (8.09%)  28 24/171 (14.04%)  43
PARAESTHESIA  1  17/173 (9.83%)  32 22/171 (12.87%)  34
SCIATICA  1  7/173 (4.05%)  10 10/171 (5.85%)  32
SOMNOLENCE  1  24/173 (13.87%)  44 20/171 (11.70%)  59
TREMOR  1  20/173 (11.56%)  44 23/171 (13.45%)  55
Psychiatric disorders     
ANXIETY  1  33/173 (19.08%)  61 42/171 (24.56%)  110
DEPRESSED MOOD  1  3/173 (1.73%)  3 11/171 (6.43%)  22
DEPRESSION  1  51/173 (29.48%)  111 58/171 (33.92%)  131
INSOMNIA  1  57/173 (32.95%)  128 48/171 (28.07%)  150
Renal and urinary disorders     
DYSURIA  1  3/173 (1.73%)  4 10/171 (5.85%)  12
Respiratory, thoracic and mediastinal disorders     
COUGH  1  69/173 (39.88%)  122 56/171 (32.75%)  120
DYSPNOEA  1  37/173 (21.39%)  98 38/171 (22.22%)  89
DYSPNOEA EXERTIONAL  1  9/173 (5.20%)  14 3/171 (1.75%)  3
EPISTAXIS  1  15/173 (8.67%)  17 22/171 (12.87%)  37
NASAL CONGESTION  1  11/173 (6.36%)  17 7/171 (4.09%)  13
PHARYNGOLARYNGEAL PAIN  1  36/173 (20.81%)  101 44/171 (25.73%)  109
PRODUCTIVE COUGH  1  19/173 (10.98%)  36 20/171 (11.70%)  30
RHINORRHOEA  1  13/173 (7.51%)  13 20/171 (11.70%)  37
Skin and subcutaneous tissue disorders     
ALOPECIA  1  67/173 (38.73%)  84 53/171 (30.99%)  70
DRY SKIN  1  24/173 (13.87%)  48 18/171 (10.53%)  23
ERYTHEMA  1  10/173 (5.78%)  14 11/171 (6.43%)  12
HYPERHIDROSIS  1  36/173 (20.81%)  55 42/171 (24.56%)  121
NIGHT SWEATS  1  21/173 (12.14%)  49 30/171 (17.54%)  73
PRURITUS  1  37/173 (21.39%)  97 30/171 (17.54%)  57
RASH  1  27/173 (15.61%)  46 23/171 (13.45%)  56
Vascular disorders     
HYPOTENSION  1  9/173 (5.20%)  14 14/171 (8.19%)  20
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
AE Preferred Terms were converted from WHO-ART dictionary to the MedDRA version 10.0
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.
Principal Investigators have the right to publish or publicly present the results of the study. Principal Investigators further agree to provide to the Sponsor thirty (30) days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication. No publication or manuscript shall contain any trade secret information of the Sponsor or any proprietary or confidential information of the Sponsor.
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: NCT03547154     History of Changes
Other Study ID Numbers: C98026
MK-4031-001 ( Other Identifier: Merck Protocol Number )
C98-026 ( Other Identifier: Schering-Plough )
First Submitted: May 24, 2018
First Posted: June 6, 2018
Results First Submitted: March 29, 2019
Results First Posted: August 12, 2019
Last Update Posted: August 12, 2019