Trial Outcomes & Findings for S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia (NCT NCT00840177)
NCT ID: NCT00840177
Last Updated: 2023-05-03
Results Overview
Participants who achieved morphological complete remission with or without incomplete blood count recovery. Per the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, morphologic complete remission requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
115 participants
Primary outcome timeframe
Up to 5 years after registration
Results posted on
2023-05-03
Participant Flow
Participant milestones
| Measure |
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting ≥ 3 months
|
Poor-risk Cohort: MDS Transformed to AML
Participants with acute myeloid leukemia (AML) who had a previous morphologically confirmed diagnosis of myelodysplastic syndrome(MDS)/Chronic Myelomonocytic Leukemia (CMML) and for which they may have received previous non-intensive therapy.
|
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting \< 6 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
29
|
50
|
|
Overall Study
Treated
|
36
|
29
|
46
|
|
Overall Study
Assessed for AEs
|
35
|
29
|
46
|
|
Overall Study
COMPLETED
|
18
|
20
|
39
|
|
Overall Study
NOT COMPLETED
|
18
|
9
|
11
|
Reasons for withdrawal
| Measure |
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting ≥ 3 months
|
Poor-risk Cohort: MDS Transformed to AML
Participants with acute myeloid leukemia (AML) who had a previous morphologically confirmed diagnosis of myelodysplastic syndrome(MDS)/Chronic Myelomonocytic Leukemia (CMML) and for which they may have received previous non-intensive therapy.
|
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting \< 6 months.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
1
|
|
Overall Study
Refusal unrelated to adverse events
|
1
|
0
|
1
|
|
Overall Study
Progression/relapse
|
2
|
0
|
0
|
|
Overall Study
Death
|
4
|
5
|
5
|
|
Overall Study
not protocol specified
|
6
|
3
|
0
|
|
Overall Study
Ineligible
|
0
|
0
|
3
|
|
Overall Study
Did not start treatment
|
0
|
0
|
1
|
Baseline Characteristics
S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month
n=36 Participants
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting ≥ 3 months
|
Poor-risk Cohort: MDS Transformed to AML
n=29 Participants
Participants with acute myeloid leukemia (AML) who had a previous morphologically confirmed diagnosis of MDS/CMML and for which they may have received previous non-intensive therapy.
|
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission
n=46 Participants
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting \< 6 months.
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.6 years
n=99 Participants
|
64.9 years
n=107 Participants
|
57.3 years
n=206 Participants
|
60.7 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
57 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
95 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
93 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 5 years after registrationPopulation: Eligible participants who started treatment
Participants who achieved morphological complete remission with or without incomplete blood count recovery. Per the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, morphologic complete remission requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL.
Outcome measures
| Measure |
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month
n=36 Participants
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting ≥ 3 months
|
Poor-risk Cohort: MDS Transformed to AML
n=29 Participants
Participants with acute myeloid leukemia (AML) who had a previous morphologically confirmed diagnosis of MDS/CMML and for which they may have received previous non-intensive therapy.
|
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission
n=46 Participants
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting \< 6 months.
|
|---|---|---|---|
|
Complete Remission (CR) Rate (Including CR With Incomplete Recovery)
|
27 Participants
|
14 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 5 years post registrationPopulation: Eligible patients who were assessed for adverse events
Number of patients with Grade 3-5 adverse events that were possibly, probably or definitely related to study drug are reported by given type of adverse event
Outcome measures
| Measure |
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month
n=35 Participants
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting ≥ 3 months
|
Poor-risk Cohort: MDS Transformed to AML
n=29 Participants
Participants with acute myeloid leukemia (AML) who had a previous morphologically confirmed diagnosis of MDS/CMML and for which they may have received previous non-intensive therapy.
|
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission
n=46 Participants
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting \< 6 months.
|
|---|---|---|---|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
AST, SGOT
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Acidosis (metabolic or respiratory)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Albumin, serum-low (hypoalbuminemia)
|
1 Participants
|
3 Participants
|
6 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Alkaline phosphatase
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Alkalosis (metabolic or respiratory)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Anorexia
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Bilirubin (hyperbilirubinemia)
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Blood/Bone Marrow-Other (Specify)
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Bone marrow cellularity
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Calcium, serum-low (hypocalcemia)
|
2 Participants
|
5 Participants
|
3 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Carbon monoxide diffusion capacity (DL(co))
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Cardiac General-Other (Specify)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Cardiac-ischemia/infarction
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Colitis, infectious (e.g., Clostridium difficile)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Conduction abnormality - Asystole
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Confusion
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Constitutional Symptoms-Other (Specify)
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Creatinine
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Diarrhea
|
3 Participants
|
4 Participants
|
8 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Distention/bloating, abdominal
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Dry mouth/salivary gland (xerostomia)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Dyspnea (shortness of breath)
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Edema: limb
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Esophagitis
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Fatigue (asthenia, lethargy, malaise)
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Febrile neutropenia
|
20 Participants
|
18 Participants
|
32 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Glucose, serum-high (hyperglycemia)
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Hemoglobin
|
11 Participants
|
14 Participants
|
21 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Hemorrhage, GI - Duodenum
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Hemorrhage, GU - Vagina
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Hemorrhage, pulmonary/upper respiratory - Nose
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Hemorrhage/Bleeding-Other (Specify)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Hypertension
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Hypotension
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Hypoxia
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Ileus, GI (functional obstruction of bowel)
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
4 Participants
|
4 Participants
|
7 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Inf (clin/microbio) w/Gr 3-4 neuts - Kidney
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
5 Participants
|
2 Participants
|
6 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Inf (clin/microbio) w/Gr 3-4 neuts - Meninges
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Inf (clin/microbio) w/Gr 3-4 neuts - Sinus
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Inf (clin/microbio) w/Gr 3-4 neuts - Skin
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Inf (clin/microbio) w/Gr 3-4 neuts - Small bowel
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Inf (clin/microbio) w/Gr 3-4 neuts - Stomach
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Infection with unknown ANC - Blood
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Infection with unknown ANC - Lung (pneumonia)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Infection with unknown ANC - Mucosa
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Infection with unknown ANC - Sinus
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Infection with unknown ANC - Small bowel NOS
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Infection-Other (Specify)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Left ventricular diastolic dysfunction
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Leukocytes (total WBC)
|
16 Participants
|
11 Participants
|
17 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Lipase
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Lymphopenia
|
6 Participants
|
5 Participants
|
9 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Magnesium, serum-high (hypermagnesemia)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Mental status
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Mucositis/stomatitis (clinical exam) - Oral cavity
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Mucositis/stomatitis (clinical exam) - Pharynx
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Mucositis/stomatitis (functional/symp) - Oral cav
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Musculoskeletal/Soft Tissue-Other (Specify)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Nausea
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Necrosis, GI - Small bowel NOS
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Neutrophils/granulocytes (ANC/AGC)
|
14 Participants
|
15 Participants
|
16 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Obstruction, GI - Small bowel NOS
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Ocular/Visual-Other (Specify)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Opportunistic inf associated w/gt=Gr 2 lymphopenia
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Pain - Abdomen NOS
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Pain - Bone
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Pain - Esophagus
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Pain - Extremity-limb
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Pain - Oral cavity
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Pain - Peritoneum
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Phosphate, serum-low (hypophosphatemia)
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Platelets
|
17 Participants
|
16 Participants
|
19 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Pleural effusion (non-malignant)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Potassium, serum-high (hyperkalemia)
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Potassium, serum-low (hypokalemia)
|
6 Participants
|
3 Participants
|
3 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Pulmonary hypertension
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Pulmonary/Upper Respiratory-Other (Specify)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Rash/desquamation
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Renal failure
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Renal/Genitourinary-Other (Specify)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
SVT and nodal arrhythmia - Atrial fibrillation
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
SVT and nodal arrhythmia - Atrial flutter
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Sodium, serum-high (hypernatremia)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Sodium, serum-low (hyponatremia)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Syncope (fainting)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Typhlitis (cecal inflammation)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Ulcer, GI - Duodenum
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Ulceration
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Vomiting
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
Weight loss
|
0 Participants
|
0 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: OS assessed for up to 5 years, median OS reportedPopulation: Eligible participants who started treatment
OS is calculated for all participants from the date of initial registration on study until death from any cause. Observations for participants last known to be alive were censored.
Outcome measures
| Measure |
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month
n=36 Participants
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting ≥ 3 months
|
Poor-risk Cohort: MDS Transformed to AML
n=29 Participants
Participants with acute myeloid leukemia (AML) who had a previous morphologically confirmed diagnosis of MDS/CMML and for which they may have received previous non-intensive therapy.
|
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission
n=46 Participants
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting \< 6 months.
|
|---|---|---|---|
|
Overall Survival (OS)
|
10 months
Interval 7.0 to 12.0
|
10 months
Interval 4.0 to 18.0
|
4 months
Interval 3.0 to 6.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: RFS assessed for up to 5 years, median RFS reportedPopulation: Eligible participants who started treatment
RFS is calculated for participants who have achieved a complete response (CR) or CR with incomplete blood count recovery (CRi). RFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse. Per the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, morphologic complete remission requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL.
Outcome measures
| Measure |
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month
n=36 Participants
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting ≥ 3 months
|
Poor-risk Cohort: MDS Transformed to AML
n=29 Participants
Participants with acute myeloid leukemia (AML) who had a previous morphologically confirmed diagnosis of MDS/CMML and for which they may have received previous non-intensive therapy.
|
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission
n=46 Participants
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting \< 6 months.
|
|---|---|---|---|
|
Relapse-free Survival (RFS)
|
9 months
Interval 5.0 to 20.0
|
19.4 months
Interval 4.3 to
The upper 95% confidence limit for the median cannot be estimated using the method of Brookmeyer and Crowley (1982).
|
2.7 months
Interval 0.3 to 18.9
|
Adverse Events
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Mnths
Serious events: 5 serious events
Other events: 34 other events
Deaths: 27 deaths
Poor-risk Cohort: MDS Transformed to AML
Serious events: 8 serious events
Other events: 28 other events
Deaths: 20 deaths
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission
Serious events: 10 serious events
Other events: 45 other events
Deaths: 41 deaths
Serious adverse events
| Measure |
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Mnths
n=35 participants at risk
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting ≥ 3 months
|
Poor-risk Cohort: MDS Transformed to AML
n=29 participants at risk
Participants with acute myeloid leukemia (AML) who had a previous morphologically confirmed diagnosis of MDS/CMML and for which they may have received previous non-intensive therapy.
|
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission
n=46 participants at risk
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting \< 6 months.
|
|---|---|---|---|
|
Cardiac disorders
Conduction abnormality - Asystole
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Atrial fibrillation
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Cardiac disorders
Cardiac General-Other
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Sinus tachycardia
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel)
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Infections and infestations
Infection with unknown ANC - Blood
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.9%
5/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Infections and infestations
Infection with unknown ANC - Small bowel NOS
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Investigations
Carbon monoxide diffusion capacity (DL(co))
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.8%
4/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Investigations
Lymphopenia
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue-Other
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Nervous system disorders
Hemorrhage, CNS
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Carbon monoxide diffusion capacity (DL(co))
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.8%
4/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Vascular disorders
Hypotension
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
Other adverse events
| Measure |
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Mnths
n=35 participants at risk
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting ≥ 3 months
|
Poor-risk Cohort: MDS Transformed to AML
n=29 participants at risk
Participants with acute myeloid leukemia (AML) who had a previous morphologically confirmed diagnosis of MDS/CMML and for which they may have received previous non-intensive therapy.
|
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission
n=46 participants at risk
Participants with previous morphologically confirmed acute myeloid leukemia (AML), and preceding remission lasting \< 6 months.
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
8.6%
3/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
24.1%
7/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
17.4%
8/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow-Other
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
60.0%
21/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
75.9%
22/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
71.7%
33/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
37.1%
13/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
72.4%
21/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
50.0%
23/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Blood and lymphatic system disorders
Lymphatics-Other
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
4.3%
2/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Atrial fibrillation
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Sinus tachycardia
|
8.6%
3/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
17.2%
5/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
15.2%
7/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Cardiac disorders
Ventricular arrhythmia - Ventricular tachycardia
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Eye disorders
Ocular/Visual-Other
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
4.3%
2/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Eye disorders
Pain - Eye
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
34.5%
10/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.0%
6/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Diarrhea
|
62.9%
22/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
86.2%
25/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
73.9%
34/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
31.0%
9/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
4.3%
2/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.9%
5/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Esophagitis
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Gastrointestinal-Other
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.8%
4/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Oral cavity
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel)
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
11.4%
4/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
17.2%
5/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
8.7%
4/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
4.3%
2/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Nausea
|
57.1%
20/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
75.9%
22/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
52.2%
24/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
20.0%
7/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
37.9%
11/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
34.8%
16/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Pain - Oral cavity
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
15.2%
7/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Pain - Stomach
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.3%
3/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
4.3%
2/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Typhlitis (cecal inflammation)
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
4.3%
2/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Gastrointestinal disorders
Vomiting
|
45.7%
16/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
44.8%
13/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
34.8%
16/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
General disorders
Constitutional Symptoms-Other
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.3%
3/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
General disorders
Edema: head and neck
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.8%
4/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
General disorders
Edema: limb
|
14.3%
5/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
48.3%
14/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
17.4%
8/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
General disorders
Edema: viscera
|
8.6%
3/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
40.0%
14/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
62.1%
18/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
39.1%
18/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.3%
3/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
General disorders
Injection site reaction/extravasation changes
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.3%
3/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
4.3%
2/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
General disorders
Pain - Chest/thorax NOS
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
17.2%
5/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
General disorders
Pain - Pain NOS
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
General disorders
Pain-Other
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
24.1%
7/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
General disorders
Rigors/chills
|
8.6%
3/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
34.5%
10/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
17.4%
8/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
11.4%
4/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.3%
3/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.0%
6/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
14.3%
5/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
17.2%
5/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
21.7%
10/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
14.3%
5/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.3%
3/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.0%
6/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums
|
8.6%
3/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
4.3%
2/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Skin
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Stomach
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Infections and infestations
Infection-Other
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.8%
4/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Injury, poisoning and procedural complications
Thrombosis/embolism (vascular access-related)
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
20.0%
7/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
20.7%
6/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
39.1%
18/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Investigations
AST, SGOT
|
14.3%
5/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
34.5%
10/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
39.1%
18/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Investigations
Alkaline phosphatase
|
11.4%
4/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
27.6%
8/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
19.6%
9/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
22.9%
8/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
24.1%
7/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
28.3%
13/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Investigations
Creatinine
|
14.3%
5/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
20.7%
6/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
17.4%
8/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Investigations
INR (of prothrombin time)
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.8%
4/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.0%
6/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Investigations
Leukocytes (total WBC)
|
45.7%
16/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
55.2%
16/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
39.1%
18/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Investigations
Lymphopenia
|
14.3%
5/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
31.0%
9/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
23.9%
11/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
40.0%
14/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
62.1%
18/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
39.1%
18/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Investigations
PTT (Partial thromboplastin time)
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
19.6%
9/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Investigations
Platelets
|
51.4%
18/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
65.5%
19/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
43.5%
20/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Investigations
Weight gain
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Investigations
Weight loss
|
11.4%
4/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.3%
3/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
17.4%
8/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
17.1%
6/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
69.0%
20/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
41.3%
19/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Metabolism and nutrition disorders
Anorexia
|
11.4%
4/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
48.3%
14/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
21.7%
10/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
25.7%
9/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
65.5%
19/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
34.8%
16/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
25.7%
9/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
37.9%
11/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
30.4%
14/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
20.7%
6/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.0%
6/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
11.4%
4/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
34.5%
10/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
26.1%
12/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
8.6%
3/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
37.9%
11/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
32.6%
15/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.8%
4/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
34.3%
12/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
69.0%
20/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
52.2%
24/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
8.6%
3/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
20.7%
6/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.9%
5/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
22.9%
8/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
34.5%
10/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
26.1%
12/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
8.6%
3/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
17.2%
5/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue-Other
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.0%
6/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
8.7%
4/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
20.7%
6/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.3%
3/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Nervous system disorders
Mental status
|
8.6%
3/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Nervous system disorders
Neurology-Other
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Nervous system disorders
Neuropathy: sensory
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Nervous system disorders
Ocular/Visual-Other
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
4.3%
2/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Nervous system disorders
Pain - Head/headache
|
17.1%
6/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
27.6%
8/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
8.7%
4/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
4.3%
2/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Psychiatric disorders
Confusion
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.3%
3/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
8.7%
4/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Psychiatric disorders
Insomnia
|
8.6%
3/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
17.2%
5/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.0%
6/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Psychiatric disorders
Mood alteration - agitation
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Psychiatric disorders
Mood alteration - anxiety
|
14.3%
5/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.8%
4/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
17.4%
8/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Psychiatric disorders
Mood alteration - depression
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.3%
3/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.9%
5/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Psychiatric disorders
Psychosis (hallucinations/delusions)
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Renal and urinary disorders
Hemorrhage, GU - Urinary NOS
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
3.4%
1/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.9%
5/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Reproductive system and breast disorders
Hemorrhage, GU - Vagina
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.3%
3/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.8%
4/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
37.9%
11/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
15.2%
7/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
11.4%
4/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
34.5%
10/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
21.7%
10/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
17.2%
5/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.0%
6/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
2.2%
1/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
17.2%
5/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.0%
6/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
8.7%
4/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.3%
3/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
4.3%
2/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.8%
4/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.9%
5/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.8%
4/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.9%
5/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
8.7%
4/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
11.4%
4/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
20.7%
6/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
4.3%
2/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
17.2%
5/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
15.2%
7/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
28.6%
10/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
51.7%
15/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
23.9%
11/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
10.3%
3/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
4.3%
2/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.5%
3/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Vascular disorders
Flushing
|
0.00%
0/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
6.9%
2/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
8.7%
4/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Vascular disorders
Hemorrhage/Bleeding-Other
|
5.7%
2/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
0.00%
0/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
4.3%
2/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Vascular disorders
Hypertension
|
2.9%
1/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
24.1%
7/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
21.7%
10/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
|
Vascular disorders
Hypotension
|
11.4%
4/35 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.8%
4/29 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
13.0%
6/46 • Up to 5 years post registration
Adverse Events (AEs) are reported by CTCAE Version 4.0. All adverse events, regardless of attribution or grade, are reported for patients who received study treatment. 1 patient in the initial cohort was taken off protocol therapy before AEs were assessed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60