KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)
Study Details
Study Description
Brief Summary
The purpose of this study is to estimate the overall response rate of subjects with relapsed or refractory Adult T-cell Leukemia-Lymphoma (ATL).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
CCR4 expression in ATL patients has been demonstrated to be very high and has been associated with shorter survival compared with CCR4-negative patients. KW-0761, a monoclonal antibody targeted to CCR4, has been shown to be safe and tolerable in several clinical trials in subjects with a variety of T-cell malignancies, including ATL, mycosis fungoides and Sézary syndrome. The objective of this study is to estimate the overall response rate of KW-0761 for subjects with relapsed or refractory ATL.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: KW-0761 anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) |
Biological: KW-0761
1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
Other Names:
|
| Active Comparator: investigator's choice Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP |
Drug: Pralatrexate
30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression
Other Names:
Drug: gemcitabine plus oxaliplatin
gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression
Other Names:
Drug: DHAP
dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Response Rate [every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first]
Overall Response Rate was determined based on the response in all compartments (lymph nodes, extranodal masses, spleen/liver, skin, peripheral blood, and bone marrow), referencing Tsukasaki, 2009 as follows: Complete Response (CR) = All compartments involved with disease must be CR; Uncertified Complete Response (CRu) = > 75% decrease in lymph nodes and/or extranodal disease with all other compartments involved with disease CR; Partial Response (PR) = If any compartment is CR/PR and all other compartments involved with disease are at least SD; Stable Disease (SD) = All compartments involved with disease are SD; Progressive Disease (PD) = PD in any compartment. Lymph node and extranodal masses response ≥50% decrease by CT, skin response ≥50% decrease in mSWAT score; blood response ≥50% decrease in malignant cells by flow cytometry; normal bone marrow if abnormal at baseline. PD equals New or ≥50% increase in any compartment.
Secondary Outcome Measures
- Progression Free Survival [From date of randomization until the date of first documented progression, start of alternative therapy, or date of death from any cause, whichever came first, up to 36 months]
Progression-free survival was defined as the time from the first date of treatment until the date that PD or death was first reported. Disease progression included PD in any compartment per ATL response criteria, clinical progression at the end of the randomized treatment, or disease progression reported during the follow-up period. The date of PD was the earliest date at which disease progression could be declared.
- Overall Survival [up to 36 months]
The estimates and summary statistics for OS were calculated based on Kaplan-Meier method, and the median OS was 4.9 months for subjects randomized to the mogamulizumab group versus 6.87 months for subjects randomized to the Investigator's Choice group.
- Change in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score [From date of randomization until the date of first documented progression, up to 36 months]
The FACT-Lym consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General [FACT-G]) and a 15-item disease-specific questionnaire (Lymphoma Subscale). The FACT-G includes 4 domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The total FACT-Lym score (0-168) was obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life. Change was calculated as the value at the last observation minus the value at baseline.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males and female subjects ≥ 18 years of age
-
Confirmed diagnosis of ATL (excluding smoldering subtype)
-
Subjects must currently have evidence of disease in at least one of the following:
-
Lymph nodes
-
Extranodal masses
-
Spleen or liver
-
Skin
-
Peripheral blood
-
Bone marrow
-
Relapsed or refractory after at least one prior systemic therapy regimen for ATL;
-
Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2 at study entry
-
Resolution of all clinically significant toxic effects of prior cancer therapy to grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0)
-
Adequate hematological, hepatic and renal function
Exclusion Criteria:
-
Smoldering subtype of ATL;
-
Lymphomatous or acute subtype subject with > 2 prior systemic therapy regimens and who has not achieved a response (CR or PR) or maintained stable disease for at least 12 weeks on last immediate prior therapy;
-
History of allogeneic transplant;
-
Autologous hematopoietic stem cell transplant within 90 days of study entry;
-
Untreated human immunodeficiency virus (HIV)
-
Has known hepatitis C. Patients who are hepatitis C antibody positive but are hepatitis C quantitative PCR negative may be enrolled;
-
Has hepatitis B based on PCR testing for hepatitis B virus DNA. Patients who are hepatitis B core antibody positive but PCR negative may be enrolled if placed on appropriate anti-hepatitis B virus prophylaxis prior to commencing treatment with KW-0761. Patients who are hepatitis B core antibody positive based on prior vaccination need not receive prophylaxis;
-
Have had a malignancy in the past two years except non-melanoma skin cancers, melanoma in situ, localized cancer of the prostate with current PSA < 0.1 µg/mL, treated thyroid cancer or cervical carcinoma in situ or ductal/lobular carcinoma in situ of the breast who is currently without evidence of disease;
-
Clinical evidence of central nervous system (CNS) involvement or metastasis. In subjects suspected of having CNS disease, an MRI of the brain and/or lumbar puncture should be done to confirm;
-
Psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit compliance with study requirements;
-
Significant uncontrolled intercurrent illness
-
Experienced allergic reactions to monoclonal antibodies or other therapeutic proteins;
-
Known active autoimmune diseases will be excluded (For example; Grave's disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease);
-
Is pregnant (confirmed by beta human chorionic gonadotrophin [β-HCG]) or lactating.
-
Prior treatment with KW-0761;
-
Initiation of treatment with systemic corticosteroids while on study is only permitted for acute and brief complications of underlying disease (e.g., hypercalcemia) or for treatment related side effects (e.g., including pre-medication for infusion reaction, nausea and vomiting). Subjects on systemic corticosteroids prior to enrollment must be off for 7 days before initiation of study treatment, unless specifically indicated for the treatment of hypercalcemia. (subjects may receive inhalation corticosteroids and replacement doses of systemic corticosteroids as needed);
-
Initiation of treatment with topical corticosteroids while on study is not permitted except to treat an acute rash. Subjects on a stable dose of medium or low potency topical corticosteroids for at least 4 weeks prior to Pre-treatment Visit may continue use at the same dose, although the investigator should attempt to taper the use to lowest dose tolerable;
-
Have had interferon-α and/or zidovudine within 1 week, or anti-neoplastic chemotherapy, radiation, immunotherapy, or investigational medications within 2 weeks of first study treatment;
-
Subjects on any immunomodulatory drug. Subjects on any immunomodulatory drug within 4 weeks of their first dose of KW-0761 are also excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 2 | University of Miami / Sylvester Comprehensive Cancer Center | Miami | Florida | United States | 33136 |
| 3 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 4 | National Cancer Institute | Bethesda | Maryland | United States | 20892 |
| 5 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 6 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 7 | Montefiore Medical Center | Bronx | New York | United States | 10467 |
| 8 | Memorial Sloan Kettering | New York | New York | United States | 10021 |
| 9 | Columbia Presbyterian | New York | New York | United States | 10032 |
| 10 | Weill Cornell Medical College | New York | New York | United States | 10065 |
| 11 | Cliniques Universitaires Saint-Luc | Bruxelles | Belgium | 1200 | |
| 12 | Hospital Universitario Professor Edgard Santos- UFBA | Salvador, Bahia | Brazil | 40110-060 | |
| 13 | Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | Sao Paulo- SP | Brazil | CEP 05403-000 | |
| 14 | CHU de Fort de France | Fort De France Cedex | France | BP 632 97261 | |
| 15 | Hospital Necker | Paris | France | 75743 | |
| 16 | Hospital Nacional Edgardo Rebagliati Martins | Lima | Peru | Lima11 | |
| 17 | Instituto Oncologico Miraflores | Lima | Peru | Lima18 | |
| 18 | Guy's Hospital | London | United Kingdom | SE1 9RT | |
| 19 | Imperial College | London | United Kingdom | W2 1PG | |
| 20 | Sandwell General Hospital | West Midlands | United Kingdom | B71 4HJ |
Sponsors and Collaborators
- Kyowa Kirin, Inc.
Investigators
- Study Director: Michael Kurman, MD, Kyowa Hakko Kirin Pharma, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PROTOCOL 0761-009
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | KW-0761 | Investigator's Choice | IC Original Then Crossover to KW-0761 |
|---|---|---|---|
| Arm/Group Description | anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression | Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression | Subjects who were randomized to the Investigator's Choice regimen could be crossed over to receive mogamulizumab upon disease progression and with permission from the Medical Monitor. |
| Period Title: Randomization Period | |||
| STARTED | 47 | 24 | 0 |
| COMPLETED | 47 | 24 | 0 |
| NOT COMPLETED | 0 | 0 | 0 |
| Period Title: Randomization Period | |||
| STARTED | 0 | 0 | 18 |
| COMPLETED | 0 | 0 | 18 |
| NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | KW-0761 | Investigator's Choice | Total |
|---|---|---|---|
| Arm/Group Description | anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression | Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression | Total of all reporting groups |
| Overall Participants | 47 | 24 | 71 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
35
74.5%
|
22
91.7%
|
57
80.3%
|
| >=65 years |
12
25.5%
|
2
8.3%
|
14
19.7%
|
| Age (years) [Mean (Full Range) ] | |||
| Mean (Full Range) [years] |
55
|
49
|
53
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
23
48.9%
|
14
58.3%
|
37
52.1%
|
| Male |
24
51.1%
|
10
41.7%
|
34
47.9%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
9
19.1%
|
6
25%
|
15
21.1%
|
| Not Hispanic or Latino |
31
66%
|
14
58.3%
|
45
63.4%
|
| Unknown or Not Reported |
7
14.9%
|
4
16.7%
|
11
15.5%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| White |
6
12.8%
|
5
20.8%
|
11
15.5%
|
| Asian |
2
4.3%
|
1
4.2%
|
3
4.2%
|
| Black or African American |
32
68.1%
|
15
62.5%
|
47
66.2%
|
| Other |
1
2.1%
|
0
0%
|
1
1.4%
|
| Not Applicable |
6
12.8%
|
3
12.5%
|
9
12.7%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
25
53.2%
|
14
58.3%
|
39
54.9%
|
| Brazil |
3
6.4%
|
0
0%
|
3
4.2%
|
| United Kingdom |
9
19.1%
|
4
16.7%
|
13
18.3%
|
| France |
6
12.8%
|
3
12.5%
|
9
12.7%
|
| Peru |
4
8.5%
|
3
12.5%
|
7
9.9%
|
Outcome Measures
| Title | Overall Response Rate |
|---|---|
| Description | Overall Response Rate was determined based on the response in all compartments (lymph nodes, extranodal masses, spleen/liver, skin, peripheral blood, and bone marrow), referencing Tsukasaki, 2009 as follows: Complete Response (CR) = All compartments involved with disease must be CR; Uncertified Complete Response (CRu) = > 75% decrease in lymph nodes and/or extranodal disease with all other compartments involved with disease CR; Partial Response (PR) = If any compartment is CR/PR and all other compartments involved with disease are at least SD; Stable Disease (SD) = All compartments involved with disease are SD; Progressive Disease (PD) = PD in any compartment. Lymph node and extranodal masses response ≥50% decrease by CT, skin response ≥50% decrease in mSWAT score; blood response ≥50% decrease in malignant cells by flow cytometry; normal bone marrow if abnormal at baseline. PD equals New or ≥50% increase in any compartment. |
| Time Frame | every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | KW-0761 | Investigator's Choice |
|---|---|---|
| Arm/Group Description | anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression | Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression |
| Measure Participants | 47 | 24 |
| Complete Response |
2
4.3%
|
0
0%
|
| Uncertified Complete Response |
0
0%
|
0
0%
|
| Partial Response |
11
23.4%
|
2
8.3%
|
| Stable Disease |
0
0%
|
4
16.7%
|
| Relapsed Disease or Progressive Disease |
16
34%
|
13
54.2%
|
| Not Assessable |
18
38.3%
|
5
20.8%
|
| Overall Response Rate (Confirmed and Unconfirmed) |
13
27.7%
|
2
8.3%
|
| Overall Response Rate Confirmed |
5
10.6%
|
0
0%
|
| Title | Progression Free Survival |
|---|---|
| Description | Progression-free survival was defined as the time from the first date of treatment until the date that PD or death was first reported. Disease progression included PD in any compartment per ATL response criteria, clinical progression at the end of the randomized treatment, or disease progression reported during the follow-up period. The date of PD was the earliest date at which disease progression could be declared. |
| Time Frame | From date of randomization until the date of first documented progression, start of alternative therapy, or date of death from any cause, whichever came first, up to 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | KW-0761 | Investigator's Choice |
|---|---|---|
| Arm/Group Description | anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression | Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression |
| Measure Participants | 47 | 24 |
| PFS Subjects (%) Alive for at Least: 1 Month |
47.5
|
44.1
|
| PFS Subjects (%) Alive for at Least: 2 Months |
29.8
|
33.0
|
| PFS Subjects (%) Alive for at Least: 3 Months |
24.4
|
26.4
|
| PFS Subjects (%) Alive for at Least: 4 Months |
18.3
|
13.2
|
| PFS Subjects (%) Alive for at Least: 5 Months |
18.3
|
0
|
| PFS Subjects (%) Alive for at Least: 6 Months |
12.2
|
0
|
| Title | Overall Survival |
|---|---|
| Description | The estimates and summary statistics for OS were calculated based on Kaplan-Meier method, and the median OS was 4.9 months for subjects randomized to the mogamulizumab group versus 6.87 months for subjects randomized to the Investigator's Choice group. |
| Time Frame | up to 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | KW-0761 | Investigator's Choice |
|---|---|---|
| Arm/Group Description | anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression | Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression |
| Measure Participants | 47 | 24 |
| Subjects (%) Alive for at Least: 1 Month |
87.0
|
91.7
|
| Subjects (%) Alive for at Least: 2 Months |
75.6
|
79.2
|
| Subjects (%) Alive for at Least: 3 Months |
59.1
|
70.8
|
| Subjects (%) Alive for at Least: 4 Months |
54.3
|
66.7
|
| Subjects (%) Alive for at Least: 5 Months |
49.5
|
54.2
|
| Subjects (%) Alive for at Least: 6 Months |
44.3
|
54.2
|
| Title | Change in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score |
|---|---|
| Description | The FACT-Lym consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General [FACT-G]) and a 15-item disease-specific questionnaire (Lymphoma Subscale). The FACT-G includes 4 domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The total FACT-Lym score (0-168) was obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life. Change was calculated as the value at the last observation minus the value at baseline. |
| Time Frame | From date of randomization until the date of first documented progression, up to 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants in Intention-to-Treat who had both the values at baseline and last observation |
| Arm/Group Title | KW-0761 | Investigator's Choice |
|---|---|---|
| Arm/Group Description | anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression | Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression |
| Measure Participants | 41 | 24 |
| Baseline |
110.1
(22.15)
|
106.8
(25.84)
|
| Last Observation Change from Baseline |
-12.1
(25.60)
|
-14.9
(25.56)
|
Adverse Events
| Time Frame | From pre-treatment visit until 90 days after the last dose, approximately three months overall | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | KW-0761 | Investigator's Choice | IC Original Then Crossover to KW-0761 | |||
| Arm/Group Description | anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression | Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression | Subjects who were randomized to the Investigator's Choice regimen could be crossed over to receive mogamulizumab upon disease progression and with permission from the Medical Monitor. | |||
All Cause Mortality |
||||||
| KW-0761 | Investigator's Choice | IC Original Then Crossover to KW-0761 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/47 (21.3%) | 1/24 (4.2%) | 12/18 (66.7%) | |||
Serious Adverse Events |
||||||
| KW-0761 | Investigator's Choice | IC Original Then Crossover to KW-0761 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 26/47 (55.3%) | 10/24 (41.7%) | 9/18 (50%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Leukocytosis | 0/47 (0%) | 0 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Thrombocytopenia | 0/47 (0%) | 0 | 2/24 (8.3%) | 2 | 0/18 (0%) | 0 |
| Cardiac disorders | ||||||
| Acute Coronary Syndrome | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Acute Myocardial Infarction | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Atrial Fibrillation | 2/47 (4.3%) | 2 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Myocarditis | 0/47 (0%) | 0 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal Distension | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Abdominal Pain | 1/47 (2.1%) | 2 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Constipation | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Haematemsis | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Ileitis | 0/47 (0%) | 0 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Nausea | 1/47 (2.1%) | 1 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Vomiting | 2/47 (4.3%) | 2 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| General disorders | ||||||
| Asthenia | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Disease Progression | 2/47 (4.3%) | 2 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Fatigue | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Multi-Organ Failure | 2/47 (4.3%) | 2 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Pyrexia | 2/47 (4.3%) | 2 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Immune system disorders | ||||||
| Anaphylactic Reaction | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Infections and infestations | ||||||
| Catheter Site Infection | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Cellulitis | 0/47 (0%) | 0 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Clostridial Infection | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Cytomegalovirus Infection | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Empyema | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Infective Thrombosis | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Lower Respiratory Tract Infection | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Oropharyngeal Candidiasis | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Pneumocystis Jiroveci Pneumonia | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Pneumonia | 3/47 (6.4%) | 4 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Post Procedural Sepsis | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Sepsis | 2/47 (4.3%) | 2 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Septic Shock | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Urosepsis | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Infusion Related Reaction | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Investigations | ||||||
| Alanine Aminotransferase Increased | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Amylase Increased | 0/47 (0%) | 0 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Aspartate Aminotransferase Increased | 1/47 (2.1%) | 1 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Bilirubin Conjugated Increased | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Blood Alkaline Phosphatase Increased | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Blood Bilirubin Increased | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Blood Lactate Dehydrogenase Increased | 0/47 (0%) | 0 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Lipase Increased | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Urine Ketone Body Present | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Weight Decreased | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Decreased Appetite | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Dehydration | 0/47 (0%) | 0 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 1 |
| Hypercalcaemia | 7/47 (14.9%) | 7 | 4/24 (16.7%) | 4 | 2/18 (11.1%) | 2 |
| Hyperglycaemia | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Hypoglycaemia | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Lactic Acidosis | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 2/18 (11.1%) | 2 |
| Tumour Lysis Syndrome | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Back Pain | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Flank Pain | 1/47 (2.1%) | 1 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Mobility Decreased | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Muscular Weakness | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Pain in Extremity | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Central Nervous System Lymphoma | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Nervous system disorders | ||||||
| Convulsion | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Headache | 0/47 (0%) | 0 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Osmotic Demyelination Syndrome | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Peripheral Sensorimotor Neuropathy | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Presyncope | 0/47 (0%) | 0 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Tremor | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Psychiatric disorders | ||||||
| Confusional State | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Renal and urinary disorders | ||||||
| Renal Failure | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Renal Failure Acute | 2/47 (4.3%) | 2 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnoea | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Plerual Effusion | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Pneumothorax | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Pulmonary Toxicity | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Respiratory Failure | 2/47 (4.3%) | 2 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||
| Dermatitis Acneiform | 0/47 (0%) | 0 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Pain of Skin | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Pruritis | 0/47 (0%) | 0 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Skin Hypopigmentation | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Skin Ulcer | 1/47 (2.1%) | 1 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| KW-0761 | Investigator's Choice | IC Original Then Crossover to KW-0761 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 45/47 (95.7%) | 24/24 (100%) | 17/18 (94.4%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 10/47 (21.3%) | 13 | 3/24 (12.5%) | 10 | 6/18 (33.3%) | 11 |
| Leukocytosis | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 2/18 (11.1%) | 2 |
| Leukopenia | 3/47 (6.4%) | 3 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Neutropenia | 4/47 (8.5%) | 10 | 4/24 (16.7%) | 8 | 2/18 (11.1%) | 3 |
| Pancytopenia | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Thrombocytopenia | 6/47 (12.8%) | 8 | 3/24 (12.5%) | 5 | 2/18 (11.1%) | 3 |
| Cardiac disorders | ||||||
| Bradycardia | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Tachycardia | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 2/18 (11.1%) | 2 |
| Endocrine disorders | ||||||
| Hypothyroidism | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Gastrointestinal disorders | ||||||
| Abdominal Distension | 1/47 (2.1%) | 1 | 2/24 (8.3%) | 2 | 2/18 (11.1%) | 3 |
| Abdominal Pain | 7/47 (14.9%) | 7 | 2/24 (8.3%) | 2 | 2/18 (11.1%) | 2 |
| Constipation | 6/47 (12.8%) | 7 | 5/24 (20.8%) | 5 | 1/18 (5.6%) | 1 |
| Diarrhoea | 3/47 (6.4%) | 3 | 7/24 (29.2%) | 9 | 2/18 (11.1%) | 2 |
| Diarrhoea Haemorrhagic | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Dry Mouth | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Gastrooesophageal Reflux Disease | 3/47 (6.4%) | 3 | 1/24 (4.2%) | 2 | 0/18 (0%) | 0 |
| Haematochezia | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Nausea | 6/47 (12.8%) | 7 | 9/24 (37.5%) | 11 | 0/18 (0%) | 0 |
| Obstruction Gastric | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Vomiting | 4/47 (8.5%) | 6 | 7/24 (29.2%) | 7 | 1/18 (5.6%) | 1 |
| General disorders | ||||||
| Asthenia | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 3/18 (16.7%) | 3 |
| Chest Pain | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Chills | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 2/18 (11.1%) | 2 |
| Fatigue | 5/47 (10.6%) | 8 | 4/24 (16.7%) | 4 | 1/18 (5.6%) | 1 |
| Gait Disturbance | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 2/18 (11.1%) | 2 |
| Malaise | 0/47 (0%) | 0 | 3/24 (12.5%) | 3 | 0/18 (0%) | 0 |
| Mucosal Inflammation | 0/47 (0%) | 0 | 2/24 (8.3%) | 2 | 0/18 (0%) | 0 |
| Oedema Peripheral | 8/47 (17%) | 8 | 4/24 (16.7%) | 4 | 3/18 (16.7%) | 3 |
| Pain | 3/47 (6.4%) | 3 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Pyrexia | 4/47 (8.5%) | 4 | 6/24 (25%) | 18 | 3/18 (16.7%) | 3 |
| Infections and infestations | ||||||
| Aspergillosis | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Candidiasis | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Clostridium Colitis | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Folliculitis | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Haemophilus Infection | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Lower Respiratory Tract Infection | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Lung Infection | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Oral Candidiasis | 3/47 (6.4%) | 3 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Pneumonia | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Upper Respiratory Tract Infection | 3/47 (6.4%) | 3 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Urinary Tract Infection | 2/47 (4.3%) | 2 | 2/24 (8.3%) | 2 | 0/18 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Contusion | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Head Injury | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Infusion Related Reaction | 21/47 (44.7%) | 23 | 0/24 (0%) | 0 | 8/18 (44.4%) | 8 |
| Investigations | ||||||
| Alanine Aminotransferase Increased | 3/47 (6.4%) | 4 | 2/24 (8.3%) | 12 | 0/18 (0%) | 0 |
| Amylase Increased | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 2 |
| Aspartate Aminotransferase Increased | 5/47 (10.6%) | 5 | 2/24 (8.3%) | 13 | 2/18 (11.1%) | 2 |
| Bilirubin Conjugated Increased | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 2/18 (11.1%) | 2 |
| Blood Alkaline Phosphatase Increased | 2/47 (4.3%) | 2 | 3/24 (12.5%) | 8 | 1/18 (5.6%) | 1 |
| Blood Bicarbonate Decreased | 3/47 (6.4%) | 3 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Blood Bilirubin Increased | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 3/18 (16.7%) | 3 |
| Blood Creatinine Increased | 5/47 (10.6%) | 5 | 2/24 (8.3%) | 2 | 1/18 (5.6%) | 1 |
| Blood Lactate Dehydrogenase Increased | 6/47 (12.8%) | 7 | 1/24 (4.2%) | 1 | 1/18 (5.6%) | 1 |
| Blood Urea Increased | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Lipase Increased | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 3 |
| Neutrophil Count Decreased | 2/47 (4.3%) | 3 | 4/24 (16.7%) | 4 | 1/18 (5.6%) | 2 |
| Platelet Count Decreased | 5/47 (10.6%) | 5 | 2/24 (8.3%) | 11 | 0/18 (0%) | 0 |
| Platelet Count Increased | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Transaminases Increased | 0/47 (0%) | 0 | 2/24 (8.3%) | 3 | 0/18 (0%) | 0 |
| Urine Output Decreased | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Weight Decreased | 2/47 (4.3%) | 2 | 2/24 (8.3%) | 2 | 0/18 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Decreased Appetite | 4/47 (8.5%) | 4 | 4/24 (16.7%) | 4 | 1/18 (5.6%) | 1 |
| Dehydration | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 3/18 (16.7%) | 3 |
| Diabetes Mellitus | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Hypercalcaemia | 5/47 (10.6%) | 7 | 4/24 (16.7%) | 8 | 3/18 (16.7%) | 3 |
| Hyperglycaemia | 3/47 (6.4%) | 4 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Hyperkalaemia | 4/47 (8.5%) | 8 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Hypernatraemia | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 3 |
| Hyperuricaemia | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Hypoalbuminaemia | 2/47 (4.3%) | 3 | 2/24 (8.3%) | 5 | 2/18 (11.1%) | 5 |
| Hypokalaemia | 4/47 (8.5%) | 4 | 3/24 (12.5%) | 5 | 3/18 (16.7%) | 4 |
| Hypomagnesaemia | 4/47 (8.5%) | 4 | 3/24 (12.5%) | 7 | 4/18 (22.2%) | 5 |
| Hyponatraemia | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 2/18 (11.1%) | 2 |
| Hypophosphataemia | 3/47 (6.4%) | 5 | 3/24 (12.5%) | 10 | 2/18 (11.1%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 3/47 (6.4%) | 4 | 1/24 (4.2%) | 1 | 2/18 (11.1%) | 2 |
| Back Pain | 3/47 (6.4%) | 3 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Bone Pain | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Flank Pain | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Groin Pain | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Muscular Weakness | 3/47 (6.4%) | 4 | 1/24 (4.2%) | 1 | 2/18 (11.1%) | 2 |
| Myalgia | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 2/18 (11.1%) | 3 |
| Pain in Extremity | 6/47 (12.8%) | 6 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Nervous system disorders | ||||||
| Dizziness | 5/47 (10.6%) | 6 | 3/24 (12.5%) | 3 | 1/18 (5.6%) | 2 |
| Headache | 4/47 (8.5%) | 4 | 7/24 (29.2%) | 7 | 0/18 (0%) | 0 |
| Somnolence | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Psychiatric disorders | ||||||
| Anxiety | 0/47 (0%) | 0 | 2/24 (8.3%) | 2 | 3/18 (16.7%) | 3 |
| Confusional State | 3/47 (6.4%) | 3 | 0/24 (0%) | 0 | 2/18 (11.1%) | 2 |
| Hallucination | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Insomnia | 5/47 (10.6%) | 5 | 2/24 (8.3%) | 2 | 1/18 (5.6%) | 1 |
| Renal and urinary disorders | ||||||
| Proteinuria | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Renal Failure Acute | 3/47 (6.4%) | 3 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Renail Impairment | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Reproductive system and breast disorders | ||||||
| Sexual Dysfunction | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Acute Pulmonary Oedema | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Atelectasis | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Cough | 7/47 (14.9%) | 7 | 2/24 (8.3%) | 2 | 1/18 (5.6%) | 1 |
| Dyspnoea | 5/47 (10.6%) | 5 | 3/24 (12.5%) | 3 | 1/18 (5.6%) | 1 |
| Epistaxis | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Lung Disorder | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Pleural Effusion | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Productive Cough | 3/47 (6.4%) | 3 | 1/24 (4.2%) | 1 | 0/18 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Alopecia | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Blood Blister | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Dermatitis Acneiform | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Drug Eruption | 9/47 (19.1%) | 15 | 0/24 (0%) | 0 | 4/18 (22.2%) | 6 |
| Dry Skin | 3/47 (6.4%) | 3 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Ecchymosis | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Hyperhydrosis | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Pruritis | 3/47 (6.4%) | 3 | 0/24 (0%) | 0 | 0/18 (0%) | 0 |
| Rash | 3/47 (6.4%) | 4 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Vascular disorders | ||||||
| Deep Vein Thrombosis | 1/47 (2.1%) | 1 | 2/24 (8.3%) | 2 | 0/18 (0%) | 0 |
| Flushing | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Hypertension | 0/47 (0%) | 0 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
| Hypotension | 4/47 (8.5%) | 4 | 0/24 (0%) | 0 | 1/18 (5.6%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Fiona Herr, Associate Director, Medical Communications |
|---|---|
| Organization | Kyowa Kirin Inc |
| Phone | 1 (908) 234-1096 |
| medinfo-US@kyowakirin.com |
- PROTOCOL 0761-009