Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-4031-001 | Other Identifier | Merck Protocol Number | |
| C98-026 | Other Identifier | Schering-Plough |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to compare the efficacy of polyethylene glycol (PEG; pegylated) interferon alfa-2b (PEG Intron, C98026) versus interferon alfa-2b (Intron® A) in the treatment of participants with newly diagnosed CML.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegylated interferon alfa-2b | Experimental | Participants received pegylated interferon alfa-2b (PEG Intron) at a dose of 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Participants may have received hydroxyurea therapy as needed prior to randomization to reduce or keep the white blood cell (WBC) count ≤50,000/μl. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity. |
|
| Interferon alfa-2b | Active Comparator | Participants received interferon alfa-2b (Intron^® A), recombinant for injection, at a dose of 5 million international units (MIU)/m^2, administered daily by SC injection. Participants may have received hydroxyurea therapy as needed prior to randomization to reduce or keep the WBC count ≤50,000/μl. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated interferon alfa-2b | Biological | Weekly SC injection of pegylated interferon alfa-2b, 6.0 microg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months | 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. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cytogenetic Response (CR) to PEG Intron and Intron A at 6 Months | 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. |
Not provided
Inclusion Criteria
Has chronic phase CML diagnosed within 3 months prior to study enrollment
Has chronic phase CML positive for Ph^1 as confirmed by cytogenetic studies, performed by a central laboratory
Has platelet count >/= 50,000/microl
Has hemoglobin >/= 9.0 g/dL
Has WBC count >/=2000/microl but </= 50,000/microl
Has adequate hepatic and renal function, as defined by the following parameters obtained within 14 days prior to initiation of study treatment
Is fully recovered from any prior major surgery and must be at least 4 weeks postoperative
Has Eastern Cooperative Oncology Group Performance Status of 0-2
Has signed a written, voluntary informed consent before study entry, is willing to participate in this study, and is willing to complete all follow-up assessments
Exclusion Criteria:
Has accelerated phase CML as defined by any of the following criteria.
Has blastic phase CML (30% myeloblasts in peripheral blood or bone marrow)
Is a candidate for and is planning to receive allogeneic, syngeneic, or autologous bone marrow transplantation within the next 12 months
Has received prior treatment for their CML, except for hydroxyurea (collection of stem cells without using high dose chemotherapy for mobilization is acceptable)
Has severe cardiovascular disease (i. e., arrhythmias requiring chronic treatment, congestive heart failure [New York Heart Association (NYHA) Class III or IV], or symptomatic ischemic heart disease)
Has a history of a neuropsychiatric disorder requiring hospitalization
Has thyroid dysfunction not responsive to therapy
Has uncontrolled diabetes mellitus
Has a history of seropositivity for human immunodeficiency virus
Has active and/or uncontrolled infection, including active hepatitis
Has a medical condition requiring chronic systemic corticosteroids
Has a history of prior malignancies within the last 5 years, except for surgically cured non-melanoma skin cancer, or cervical carcinoma in situ
Has received any experimental therapy within 30 days prior to enrollment in this study
Is known to be actively abusing alcohol or drugs
Is pregnant, nursing, or of reproductive potential and is not practicing an effective means of contraception
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | INTRON A (Interferon Alfa-2b) | 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. |
| FG001 | PEG Intron (Pegylated Interferon Alfa-2b) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Interferon alfa-2b | Biological | Daily SC injection of interferon alfa-2b, 5 MIU/m^2 |
|
|
| 6 months |
| Number of Participants With Hematologic Responses to PEG Intron and Intron A at 6 Months | 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. | 6 months |
| Number of Participants With Overall Survival | 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. | Up to 2 years (24 months), and beyond |
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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | INTRON A (Interferon Alfa-2b) | 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. |
| BG001 | PEG Intron (Pegylated Interferon Alfa-2b) | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months | 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. | All randomized participants analyzed on an intent-to-treat basis. | Posted | Count of Participants | Participants | Up to 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cytogenetic Response (CR) to PEG Intron and Intron A at 6 Months | 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. | All randomized participants who received at least one dose of assigned treatment | Posted | Count of Participants | Participants | 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hematologic Responses to PEG Intron and Intron A at 6 Months | 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. | All randomized participants who received at least one dose of assigned treatment | Posted | Count of Participants | Participants | 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Overall Survival | 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. | All randomized participants who received at least one dose of assigned treatment | Posted | Count of Participants | Participants | Up to 2 years (24 months), and beyond |
|
Up to One Year
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | INTRON A, 5 MIU/m^2 Daily | 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. | 15 | 173 | 62 | 173 | 170 | 173 |
| EG001 | PEG-Intron, 6.0 mcg/kg Weekly | 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. | 17 | 171 | 74 | 171 | 168 | 171 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERGAMMAGLOBULINAEMIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CYANOSIS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TACHYARRHYTHMIA | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERTHYROIDISM | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
| |
| OCULAR TOXICITY | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VISUAL ACUITY REDUCED | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DUODENAL ULCER | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DUODENITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HIATUS HERNIA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MOUTH ULCERATION | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HERNIA | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERTHERMIA | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPOTHERMIA | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CYTOLYTIC HEPATITIS | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HEPATOMEGALY | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HEPATOTOXICITY | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| JAUNDICE | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| FUNGAL INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| INFECTED CYST | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| INJECTION SITE ABSCESS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL ABSCESS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE ABNORMAL | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| BODY TEMPERATURE INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| HEPATITIS B VIRUS | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| LABORATORY TEST ABNORMAL | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| TRANSAMINASES INCREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CELL DEATH | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPOVOLAEMIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BLAST CELL CRISIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| BLAST CRISIS IN MYELOGENOUS LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| NON-HODGKIN'S LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| THYROID NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| COMA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GRAND MAL CONVULSION | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PARESIS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| STATUS EPILEPTICUS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SYNCOPE VASOVAGAL | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| COMPLETED SUICIDE | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CYSTOCELE | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| METRORRHAGIA | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PLEURISY | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| AORTIC ANEURYSM | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CIRCULATORY COLLAPSE | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VENA CAVA THROMBOSIS | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| EAR PAIN | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TINNITUS | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| EYE PAIN | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| APHTHOUS STOMATITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GINGIVAL BLEEDING | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ORAL PAIN | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| STOMACH DISCOMFORT | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| FEELING COLD | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INJECTION SITE ERYTHEMA | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INJECTION SITE PAIN | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INJECTION SITE RASH | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INJECTION SITE REACTION | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| IRRITABILITY | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| THIRST | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| AGEUSIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| AMNESIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DEPRESSED MOOD | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
AE Preferred Terms were converted from WHO-ART dictionary to the MedDRA version 10.0
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
| D000077190 | Interferon alpha-2 |
| ID | Term |
|---|---|
| D016898 | Interferon-alpha |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
| Minor Respnse |
|
| No Respnse |
|
| Discontinued or No Hematologic CR at Month 6 |
|
| Participants with Missing Data |
|
|
|
|
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. |
|
|
|
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.
|
|
|