MACS2030: Exploratory Phase II Study of INC424 Patients With Primary Myelofibrosis (PMF) or Post Polycythaemia Myelofibrosis (PPV MF) or Post Essential Thrombocythaemia Myelofibrosis (PET-MF)
Study Details
Study Description
Brief Summary
The primary objective of this study is to evaluate the efficacy of INC424 in patients with PMF, PPV MF, or PET-MF using a composite measure of either an objective endpoint (> 50% reduction in splenomegaly using palpitation at 48 weeks) and/or a subjective endpoint (>50% reduction in total symptom score at 48 weeks).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: INC424 Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily. |
Drug: INC424
Ruxolitinib was provided in 5 mg tablets, packaged in bottles. 15 - 20 mg (dose based on Baseline platelet count) twice daily.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Treatment Success [48 Weeks]
Treatment success was defined as a 50% or greater reduction in palpable spleen length versus baseline at 48 weeks and/or a 50% or greater improvement in total symptom score (derived from the MF symptom assessment form (MFSAF) questionnaire) versus baseline at the week 48 time point. The MFSAF assesses the following symptoms (all scored from absent (0) to worst imaginable (10)): general fatigue, abdominal pain (and discomfort), inactivity (ability to move and walk around), cough, night sweats, itching (pruritus), bone pain (diffuse not joint pain or arthritis), fever, change in appetite/unintentional weight loss (or gain) in past 6 months, overall quality of life (QoL).
Secondary Outcome Measures
- Percentage of Participants With Best Overall Response [week 48]
Response to treatment and disease progression was assessed by physical examination, specifically assessing changes in spleen size by palpation. Disease response and progression was evaluated using the International Working Group for myelofibrosis Research and Treatment Response Criteria.
- Change From Baseline in Myelofibrosis Symptoms Assessment Form (MF-SAF) [Baseline, week 4, week 12, week 24, week 48]
The MF-SAF consists of seven questions about key symptoms and impact of MF. Questions are scored on a scale of 0-10, with higher scores indicating more severe symptoms and greater inactivity. Questions 1-6, which together comprise a Total Symptom Score (TSS), investigate the following symptoms: night sweats, pruritus/itching, abdominal discomfort, pain under the ribs, early satiety and bone/muscle pain. Question 7 asks patients to report levels of inactivity. The TSS reflects the sum of the scores of these symptoms excluding inactivity, with the maximum possible score being 60 (most severe symptom experienced).
- Change From Baseline in EQ5D Preference Index (5 Level EuroQol Questionnaire Determining Quality of Life) From Baseline [Baseline, week 4, week 12, week 24, week 48]
The EQ-5D is a standardized instrument used for measuring health outcomes in a wide range of health conditions and treatment. It consists of a descriptive system and a visual analogue scale (EQ-VAS). The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The EQ-VAS records the participant's self-rated health on a vertical, VAS where the endpoints are labeled 'best imaginable health state' and 'worst imaginable health state'. The EQ-5D health state was converted to a single summary index by applying a formula that attaches a weight to each of the levels in each dimension. The final EQ5D preference index scores range from 0 to 1 with higher scores indicating better health.
- Number of Hospitalizations [week 12, week 24, week 26, week 48]
Medical resource utilization (MRU) was assessed according to the number of hospitalizations.
- Duration of Hospitalizations [week 48]
MRU was assessed according to the mean duration of hospitalization visits.
- Number of Accident & Emergency Visits From Baseline [baseline to week 12, week 12 to week 24, week 24 to week 36, week 36 to week 48]
MRU was assessed according to the number of accidents and emergency room visits.
- Number of General Practitioner (GP), Specialists' and Urgent Care Visits [baseline to week 12, week 12 to, week 24, week 24 to week 36, week 36 to week 48]
MRU was assessed according to the number of GP, specialists', and urgent care visits.
- Percentage of Participants With Transfusion Dependency Status [baseline (BL), end of treatment (up to 28 days post last treatment) (EOT)]
Transfusion dependency status from baseline through the end of study was assessed. New onset of transfusion dependency was defined as the use of 2 or more units of red blood cell products during the 8 weeks prior to a study visit. New onset of transfusion independency was defined as the use of 0 or 1 unit of red blood cell products during the 8 weeks prior to a study visit.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients must not be eligible for another ongoing INC424 clinical trial.
-
Patients must be diagnosed with PMF, PPV MF or PET-MF, according to the 2008 revised World Health Organization criteria irrespective of JAK2 mutation status.
-
Patients with PMF requiring therapy must be classified as high risk (3 prognostic factors) OR intermediate risk level 2 (2 prognostic factors, no more), OR intermediate risk level 1 (1 prognostic factor, no more) with an enlarged spleen. The prognostic factors, defined by the International Working Group are:
-
Age > 65 years;
-
Presence of constitutional symptoms (weight loss, fever, night sweats); marked anemia (Hgb < 10g/dL)*;
-
Leukocytosis (history of WBC > 25 x109/L);
-
Circulating blasts > 1%. • A hemoglobin value < 10 g/dL must be demonstrated during the Screening Visit for patients who are not transfusion dependent. Patients receiving regular transfusions of packed red blood cells will be considered to have hemoglobin < 10 g/dL for the purpose of evaluation of risk factors.
-
Patients with Intermediate-1 disease and splenomegaly must have a palpable spleen measuring 5 cm or greater from the costal margin to the point of greatest splenic protrusion.
-
Patients must have a peripheral blood blast count of < 10%.
-
Patients with adequate liver function defined as direct bilirubin ≤ 2.0 x ULN and ALT ≤ 2.5 x ULN.
-
Patients with adequate renal function defined as serum creatinine ≤ 2 x ULN.
-
Patients with an ECOG performance status of 0, 1, or 2 (Appendix 5).
Exclusion criteria:
-
Patients eligible for hematopoietic stem cell transplantation (suitable candidate and a suitable donor is available).
-
Patients with history of malignancy in past 3 years except for treated, early-stage squamous or basal cell carcinoma in situ.
-
Patients undergoing treatment with hematopoietic growth factor receptor agonists (i.e., erythropoietin [Epo], granulocyte colony stimulating factor (GCSF [Neupogen; Neulasta], romiplostim, eltrombopag) at any time within 2 weeks prior to Screening or 4 weeks prior to Baseline.
-
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral INC424 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
-
Patients with cardiac disease which in the Investigator's opinion may jeopardize the safety of the patient or the compliance with the protocol.
-
Patients with clinically significant bacterial, fungal, parasitic or viral infection which require therapy. Patients with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed.
-
Patients with known active hepatitis A, B, C or who are HIV-positive.
-
Patients with inadequate bone marrow reserve as demonstrated by:
-
Absolute neutrophil count (ANC) that is ≤ 1000/µL.
-
Platelet count that is < 100,000/µL without the assistance of growth factors, thrombopoietic factors or platelet transfusions.
-
Patients with any history of platelet counts < 50,000/µL or ANC < 500/µL except during treatment for a myeloproliferative disorder or treatment with cytotoxic therapy for any other reason.
-
Patients with coagulation parameters (PT, PTT, INR) ≥ 1.5.
-
Patients with known hypersensitivity to INC424 or other JAK1/2 inhibitors, or to their excipients.
-
Patients under ongoing treatment with another investigational medication or having been treated with an investigational medication within 30 days of screening.
-
Patients with any concurrent condition that, in the Investigator's opinion would jeopardize the safety of the patient or compliance with the protocol.
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Cardiff | Wales | United Kingdom | CF14 4XN |
| 2 | Novartis Investigative Site | Bournemouth | United Kingdom | BH7 7DW | |
| 3 | Novartis Investigative Site | East Yorkshire | United Kingdom | HU16 5JQ | |
| 4 | Novartis Investigative Site | Edinburgh | United Kingdom | EH4 2XU | |
| 5 | Novartis Investigative Site | Leicester | United Kingdom | LE7 5WW | |
| 6 | Novartis Investigative Site | Liverpool | United Kingdom | L7 8XP | |
| 7 | Novartis Investigative Site | London | United Kingdom | SE1 9RT | |
| 8 | Novartis Investigative Site | London | United Kingdom | W12 0HS | |
| 9 | Novartis Investigative Site | Manchester | United Kingdom | M13 9NT | |
| 10 | Novartis Investigative Site | Oxford | United Kingdom | OX3 7LJ |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Study Director, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CINC424AGB02
- 2011-005066-38
Study Results
Participant Flow
| Recruitment Details | 54 patients were screened. 48 patients were enrolled as planned. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | INC424 |
|---|---|
| Arm/Group Description | Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily. |
| Period Title: Overall Study | |
| STARTED | 48 |
| COMPLETED | 31 |
| NOT COMPLETED | 17 |
Baseline Characteristics
| Arm/Group Title | INC424 |
|---|---|
| Arm/Group Description | Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily. |
| Overall Participants | 48 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
69.12
(10.419)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
21
43.8%
|
| Male |
27
56.3%
|
Outcome Measures
| Title | Percentage of Participants With Treatment Success |
|---|---|
| Description | Treatment success was defined as a 50% or greater reduction in palpable spleen length versus baseline at 48 weeks and/or a 50% or greater improvement in total symptom score (derived from the MF symptom assessment form (MFSAF) questionnaire) versus baseline at the week 48 time point. The MFSAF assesses the following symptoms (all scored from absent (0) to worst imaginable (10)): general fatigue, abdominal pain (and discomfort), inactivity (ability to move and walk around), cough, night sweats, itching (pruritus), bone pain (diffuse not joint pain or arthritis), fever, change in appetite/unintentional weight loss (or gain) in past 6 months, overall quality of life (QoL). |
| Time Frame | 48 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment. |
| Arm/Group Title | INC424 |
|---|---|
| Arm/Group Description | Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily. |
| Measure Participants | 48 |
| Number [Percentage of participants] |
50
104.2%
|
| Title | Percentage of Participants With Best Overall Response |
|---|---|
| Description | Response to treatment and disease progression was assessed by physical examination, specifically assessing changes in spleen size by palpation. Disease response and progression was evaluated using the International Working Group for myelofibrosis Research and Treatment Response Criteria. |
| Time Frame | week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS): The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment. |
| Arm/Group Title | INC424 |
|---|---|
| Arm/Group Description | Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily. |
| Measure Participants | 48 |
| Clinical improvement |
6.3
13.1%
|
| Complete response |
6.3
13.1%
|
| Partial response |
39.6
82.5%
|
| Stable disease |
47.9
99.8%
|
| Title | Change From Baseline in Myelofibrosis Symptoms Assessment Form (MF-SAF) |
|---|---|
| Description | The MF-SAF consists of seven questions about key symptoms and impact of MF. Questions are scored on a scale of 0-10, with higher scores indicating more severe symptoms and greater inactivity. Questions 1-6, which together comprise a Total Symptom Score (TSS), investigate the following symptoms: night sweats, pruritus/itching, abdominal discomfort, pain under the ribs, early satiety and bone/muscle pain. Question 7 asks patients to report levels of inactivity. The TSS reflects the sum of the scores of these symptoms excluding inactivity, with the maximum possible score being 60 (most severe symptom experienced). |
| Time Frame | Baseline, week 4, week 12, week 24, week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only participants from the full analysis set (FAS), who had evaluable measurements at both baseline and the post-baseline week time point, was included in the analysis for that time point. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment. |
| Arm/Group Title | INC424 |
|---|---|
| Arm/Group Description | Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily. |
| Measure Participants | 48 |
| Week 4 (n=37) |
-8.78
(10.638)
|
| Week 12 (n=35) |
-8.46
(12.871)
|
| Week 24 (n=30) |
-9.13
(11.950)
|
| Week 48 (n=18) |
-7.83
(9.966)
|
| Title | Change From Baseline in EQ5D Preference Index (5 Level EuroQol Questionnaire Determining Quality of Life) From Baseline |
|---|---|
| Description | The EQ-5D is a standardized instrument used for measuring health outcomes in a wide range of health conditions and treatment. It consists of a descriptive system and a visual analogue scale (EQ-VAS). The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The EQ-VAS records the participant's self-rated health on a vertical, VAS where the endpoints are labeled 'best imaginable health state' and 'worst imaginable health state'. The EQ-5D health state was converted to a single summary index by applying a formula that attaches a weight to each of the levels in each dimension. The final EQ5D preference index scores range from 0 to 1 with higher scores indicating better health. |
| Time Frame | Baseline, week 4, week 12, week 24, week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only participants from the full analysis set (FAS), who had evaluable measurements at both baseline and the post-baseline week time point, was included in the analysis for that time point. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment. |
| Arm/Group Title | INC424 |
|---|---|
| Arm/Group Description | Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily. |
| Measure Participants | 48 |
| week 4 (n=40) |
0.06
(0.173)
|
| week 12 (n=38) |
0.05
(0.178)
|
| week 24 (n=34) |
0.05
(0.231)
|
| week 48 (n=29) |
0.03
(0.222)
|
| Title | Number of Hospitalizations |
|---|---|
| Description | Medical resource utilization (MRU) was assessed according to the number of hospitalizations. |
| Time Frame | week 12, week 24, week 26, week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only participants from the full analysis set (FAS), who had evaluable measurements at the post-baseline week time point, were included in the analysis for that time point. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment. |
| Arm/Group Title | INC424 |
|---|---|
| Arm/Group Description | Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily. |
| Measure Participants | 48 |
| week 12 (n=48) |
0.10
(0.371)
|
| week 24 (n=40) |
0.03
(0.158)
|
| week 36 (n=37) |
0.05
(0.229)
|
| week 48 (n=35) |
0.09
(0.284)
|
| Title | Duration of Hospitalizations |
|---|---|
| Description | MRU was assessed according to the mean duration of hospitalization visits. |
| Time Frame | week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants from the full analysis set, who were hospitalized between baseline and week 48, were included in the analysis. |
| Arm/Group Title | INC424 |
|---|---|
| Arm/Group Description | Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily. |
| Measure Participants | 9 |
| Mean (Standard Deviation) [days] |
9.00
(5.852)
|
| Title | Number of Accident & Emergency Visits From Baseline |
|---|---|
| Description | MRU was assessed according to the number of accidents and emergency room visits. |
| Time Frame | baseline to week 12, week 12 to week 24, week 24 to week 36, week 36 to week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only participants from the full analysis set (FAS), who had evaluable measurements at each timeframe, e.g. from baseline to week 12, were included in the analysis for that timeframe. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment. |
| Arm/Group Title | INC424 |
|---|---|
| Arm/Group Description | Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily. |
| Measure Participants | 48 |
| baseline to week 12 (n=48) |
0.00
(0.412)
|
| week 12 to week 24 (n=39) |
0.00
(0.160)
|
| week 24 to week 36 (n=33) |
0.00
(0.415)
|
| week 36 to week 48 (n=33) |
0.00
(0.242)
|
| Title | Number of General Practitioner (GP), Specialists' and Urgent Care Visits |
|---|---|
| Description | MRU was assessed according to the number of GP, specialists', and urgent care visits. |
| Time Frame | baseline to week 12, week 12 to, week 24, week 24 to week 36, week 36 to week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only participants from the full analysis set (FAS), who had evaluable measurements at each timeframe, e.g. from baseline to week 12, were included in the analysis for that timeframe. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment. |
| Arm/Group Title | INC424 |
|---|---|
| Arm/Group Description | Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily. |
| Measure Participants | 48 |
| GP visits, baseline to week 12 (n=45) |
0.0
|
| GP visits, week 12 to week 24 (n=36) |
0.0
|
| GP visits, week 24 to week 36 (n=33) |
0.0
|
| GP visits, week 36 to week 48 (n=33) |
0.0
|
| Specialists visits, baseline to week 12 (n=47) |
0.00
|
| Specialists visits, week 12 to week 24 (n=36) |
0.00
|
| Specialists visits, week 24 to week 36 (n=33) |
0.00
|
| Specialists visits, week 36 to week 48 (n=33) |
0.00
|
| Urgent care visits, baseline to week 12 (n=48) |
0.00
|
| Urgent care visits, week 12 to week 24 (n=39) |
0.00
|
| Urgent care visits, week 24 to week 36 (n=33) |
0.00
|
| Urgent care visits, week 36 to week 48 (n=33) |
0.00
|
| Title | Percentage of Participants With Transfusion Dependency Status |
|---|---|
| Description | Transfusion dependency status from baseline through the end of study was assessed. New onset of transfusion dependency was defined as the use of 2 or more units of red blood cell products during the 8 weeks prior to a study visit. New onset of transfusion independency was defined as the use of 0 or 1 unit of red blood cell products during the 8 weeks prior to a study visit. |
| Time Frame | baseline (BL), end of treatment (up to 28 days post last treatment) (EOT) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment. |
| Arm/Group Title | INC424 |
|---|---|
| Arm/Group Description | Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily. |
| Measure Participants | 48 |
| From independency at BL to independency at EOT |
0.0
0%
|
| From dependency at BL to independency at EOT |
2.1
4.4%
|
| From missing at BL to independency at EOT |
0.0
0%
|
| From independency at BL to dependency at EOT |
0.0
0%
|
| From dependency at BL to dependency at EOT |
10.4
21.7%
|
| From missing at BL to dependency at EOT |
35.4
73.8%
|
| From independency at BL to missing at EOT |
0.0
0%
|
| From dependency at BL to missing at EOT |
0.0
0%
|
| From missing at BL to missing at EOT |
52.1
108.5%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | INC424 | |
| Arm/Group Description | Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily. | |
All Cause Mortality |
||
| INC424 | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| INC424 | ||
| Affected / at Risk (%) | # Events | |
| Total | 23/48 (47.9%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 3/48 (6.3%) | |
| Febrile neutropenia | 1/48 (2.1%) | |
| Splenomegaly | 2/48 (4.2%) | |
| Thrombocytopenia | 1/48 (2.1%) | |
| Cardiac disorders | ||
| Atrial fibrillation | 1/48 (2.1%) | |
| Eye disorders | ||
| Cataract | 1/48 (2.1%) | |
| Eyelid ptosis | 1/48 (2.1%) | |
| Gastrointestinal disorders | ||
| Abdominal pain | 2/48 (4.2%) | |
| Diarrhoea | 1/48 (2.1%) | |
| Dysphagia | 1/48 (2.1%) | |
| Vomiting | 1/48 (2.1%) | |
| General disorders | ||
| Hernia | 1/48 (2.1%) | |
| Pyrexia | 1/48 (2.1%) | |
| Infections and infestations | ||
| Bronchopneumonia | 1/48 (2.1%) | |
| Infected skin ulcer | 1/48 (2.1%) | |
| Kidney infection | 1/48 (2.1%) | |
| Lower respiratory tract infection | 1/48 (2.1%) | |
| Progressive multifocal leukoencephalopathy | 1/48 (2.1%) | |
| Staphylococcal sepsis | 2/48 (4.2%) | |
| Injury, poisoning and procedural complications | ||
| Fall | 1/48 (2.1%) | |
| Musculoskeletal and connective tissue disorders | ||
| Pain in extremity | 1/48 (2.1%) | |
| Nervous system disorders | ||
| Dizziness | 1/48 (2.1%) | |
| Dysarthria | 1/48 (2.1%) | |
| Migraine | 1/48 (2.1%) | |
| VIIth nerve paralysis | 1/48 (2.1%) | |
| Psychiatric disorders | ||
| Disorientation | 1/48 (2.1%) | |
| Renal and urinary disorders | ||
| Renal impairment | 1/48 (2.1%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Chronic obstructive pulmonary disease | 1/48 (2.1%) | |
| Cough | 1/48 (2.1%) | |
| Dyspnoea | 2/48 (4.2%) | |
| Epistaxis | 1/48 (2.1%) | |
| Skin and subcutaneous tissue disorders | ||
| Skin lesion | 1/48 (2.1%) | |
| Surgical and medical procedures | ||
| Cataract operation | 1/48 (2.1%) | |
Other (Not Including Serious) Adverse Events |
||
| INC424 | ||
| Affected / at Risk (%) | # Events | |
| Total | 47/48 (97.9%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 20/48 (41.7%) | |
| Neutropenia | 3/48 (6.3%) | |
| Thrombocytopenia | 17/48 (35.4%) | |
| Gastrointestinal disorders | ||
| Abdominal distension | 3/48 (6.3%) | |
| Abdominal pain | 11/48 (22.9%) | |
| Abdominal pain upper | 3/48 (6.3%) | |
| Constipation | 3/48 (6.3%) | |
| Diarrhoea | 11/48 (22.9%) | |
| Mouth ulceration | 4/48 (8.3%) | |
| Nausea | 7/48 (14.6%) | |
| Vomiting | 4/48 (8.3%) | |
| General disorders | ||
| Fatigue | 11/48 (22.9%) | |
| Pyrexia | 5/48 (10.4%) | |
| Infections and infestations | ||
| Lower respiratory tract infection | 7/48 (14.6%) | |
| Nasopharyngitis | 3/48 (6.3%) | |
| Upper respiratory tract infection | 5/48 (10.4%) | |
| Urinary tract infection | 8/48 (16.7%) | |
| Injury, poisoning and procedural complications | ||
| Contusion | 11/48 (22.9%) | |
| Fall | 6/48 (12.5%) | |
| Investigations | ||
| Alanine aminotransferase increased | 4/48 (8.3%) | |
| Platelet count decreased | 3/48 (6.3%) | |
| Weight increased | 3/48 (6.3%) | |
| Metabolism and nutrition disorders | ||
| Gout | 5/48 (10.4%) | |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 4/48 (8.3%) | |
| Back pain | 6/48 (12.5%) | |
| Flank pain | 3/48 (6.3%) | |
| Muscle spasms | 7/48 (14.6%) | |
| Pain in extremity | 4/48 (8.3%) | |
| Nervous system disorders | ||
| Dizziness | 9/48 (18.8%) | |
| Headache | 11/48 (22.9%) | |
| Lethargy | 10/48 (20.8%) | |
| Paraesthesia | 3/48 (6.3%) | |
| Psychiatric disorders | ||
| Depression | 3/48 (6.3%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 5/48 (10.4%) | |
| Dyspnoea | 6/48 (12.5%) | |
| Epistaxis | 12/48 (25%) | |
| Skin and subcutaneous tissue disorders | ||
| Alopecia | 3/48 (6.3%) | |
| Hyperhidrosis | 3/48 (6.3%) | |
| Night sweats | 6/48 (12.5%) | |
| Pruritus | 5/48 (10.4%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 862-778-8300 |
- CINC424AGB02
- 2011-005066-38