Trial Outcomes & Findings for A Phase II Study of Allo-HCT for B-Cell NHL Using Zevalin, Fludarabine and Melphalan (NCT NCT00577278)
NCT ID: NCT00577278
Last Updated: 2024-02-16
Results Overview
The primary endpoint was 2-year cumulative incidence of relapse/progression (RP), defined as time from alloHCT to disease recurrence or progression. Cumulative incidences for RP was generated in a competing-risk setting, given that death events were competing events.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
From the initial treatment to the last disease assessment, up to two years
Results posted on
2024-02-16
Participant Flow
Participant milestones
| Measure |
0.4 mCi 90Y-Ibritumomab Tiuxetan
Patients receive rituximab IV followed by indium In-111 ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. Patients undergo APBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO and sirolimus PO beginning on day -3 and continuing for up to 6 months with taper.
rituximab: Given IV fludarabine phosphate: Given IV melphalan: Given IV sirolimus: Given PO tacrolimus: Given PO or IV allogeneic hematopoietic stem cell transplantation: Undergo APBSCT indium In 111 ibritumomab tiuxetan: Given IV yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase II Study of Allo-HCT for B-Cell NHL Using Zevalin, Fludarabine and Melphalan
Baseline characteristics by cohort
| Measure |
0.4 mCi 90Y-Ibritumomab Tiuxetan
n=41 Participants
Patients receive rituximab IV followed by indium In-111 ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. Patients undergo APBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO and sirolimus PO beginning on day -3 and continuing for up to 6 months with taper.
rituximab: Given IV fludarabine phosphate: Given IV melphalan: Given IV sirolimus: Given PO tacrolimus: Given PO or IV allogeneic hematopoietic stem cell transplantation: Undergo APBSCT indium In 111 ibritumomab tiuxetan: Given IV yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
Age, Continuous
|
55 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From the initial treatment to the last disease assessment, up to two yearsThe primary endpoint was 2-year cumulative incidence of relapse/progression (RP), defined as time from alloHCT to disease recurrence or progression. Cumulative incidences for RP was generated in a competing-risk setting, given that death events were competing events.
Outcome measures
| Measure |
0.4 mCi 90Y-Ibritumomab Tiuxetan
n=41 Participants
Patients receive rituximab IV followed by indium In-111 ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. Patients undergo APBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO and sirolimus PO beginning on day -3 and continuing for up to 6 months with taper.
rituximab: Given IV fludarabine phosphate: Given IV melphalan: Given IV sirolimus: Given PO tacrolimus: Given PO or IV allogeneic hematopoietic stem cell transplantation: Undergo APBSCT indium In 111 ibritumomab tiuxetan: Given IV yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
Relapse/Progression Rate at Two Years
|
20 percentage of cumulative incidence
Interval 10.0 to 36.0
|
SECONDARY outcome
Timeframe: From the initial treatment to the last disease assessment, up to two yearsOverall survival (OS) was measured from initial treatment to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula.
Outcome measures
| Measure |
0.4 mCi 90Y-Ibritumomab Tiuxetan
n=41 Participants
Patients receive rituximab IV followed by indium In-111 ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. Patients undergo APBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO and sirolimus PO beginning on day -3 and continuing for up to 6 months with taper.
rituximab: Given IV fludarabine phosphate: Given IV melphalan: Given IV sirolimus: Given PO tacrolimus: Given PO or IV allogeneic hematopoietic stem cell transplantation: Undergo APBSCT indium In 111 ibritumomab tiuxetan: Given IV yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
Overall Survival at Two Years
|
63 percentage of survival probability
Interval 47.0 to 76.0
|
SECONDARY outcome
Timeframe: From the initial treatment to the last disease assessment, up to two yearsProgression-free survival (PFS) was measured from initial treatment to disease progression or death from any cause, whichever came first. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula.
Outcome measures
| Measure |
0.4 mCi 90Y-Ibritumomab Tiuxetan
n=41 Participants
Patients receive rituximab IV followed by indium In-111 ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. Patients undergo APBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO and sirolimus PO beginning on day -3 and continuing for up to 6 months with taper.
rituximab: Given IV fludarabine phosphate: Given IV melphalan: Given IV sirolimus: Given PO tacrolimus: Given PO or IV allogeneic hematopoietic stem cell transplantation: Undergo APBSCT indium In 111 ibritumomab tiuxetan: Given IV yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
Progression-free Survival at Two Years
|
61 percentage of survival probability
Interval 44.0 to 74.0
|
Adverse Events
0.4 mCi 90Y-Ibritumomab Tiuxetan
Serious events: 28 serious events
Other events: 41 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
0.4 mCi 90Y-Ibritumomab Tiuxetan
n=41 participants at risk
Patients receive rituximab IV followed by indium In-111 ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. Patients undergo APBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO and sirolimus PO beginning on day -3 and continuing for up to 6 months with taper.
rituximab: Given IV fludarabine phosphate: Given IV melphalan: Given IV sirolimus: Given PO tacrolimus: Given PO or IV allogeneic hematopoietic stem cell transplantation: Undergo APBSCT indium In 111 ibritumomab tiuxetan: Given IV yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Chyle or lymph leakage
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Hemorrhage, GI
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Hemorrhage, pulmonary/upper respiratory
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Thrombosis/embolism (vascular access-related)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
7.3%
3/41 • Number of events 4 • From initial treatment to off study, up to 5 years.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Cardiac disorders
Myocarditis
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Cardiac disorders
Pericarditis
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Colitis
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Dehydration
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
17.1%
7/41 • Number of events 9 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Nausea
|
4.9%
2/41 • Number of events 4 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
2/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
General disorders
Fever
|
9.8%
4/41 • Number of events 4 • From initial treatment to off study, up to 5 years.
|
|
General disorders
Pain
|
7.3%
3/41 • Number of events 10 • From initial treatment to off study, up to 5 years.
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other (Specify, __)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Hepatobiliary disorders
Pancreatitis
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Febrile neutropenia
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
|
9.8%
4/41 • Number of events 5 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
41.5%
17/41 • Number of events 34 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Infection, Bacterial
|
17.1%
7/41 • Number of events 8 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Infection, Fungal
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Infection, Viral
|
7.3%
3/41 • Number of events 4 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Opportunistic infection associated with >=Grade 2 Lymphopenia
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Viral hepatitis
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Acidosis (metabolic or respiratory)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Alkaline phosphatase
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Amylase
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Lipase
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Sodium, serum-low (hyponatremia)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy - possibly related to cancer treatment (Specify, __)
|
12.2%
5/41 • Number of events 26 • From initial treatment to off study, up to 5 years.
|
|
Nervous system disorders
Mood alteration
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Nervous system disorders
Syncope (fainting)
|
4.9%
2/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Renal and urinary disorders
Obstruction, GU
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Renal and urinary disorders
Renal failure
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.3%
3/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Induration/fibrosis (skin and subcutaneous tissue)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
Other adverse events
| Measure |
0.4 mCi 90Y-Ibritumomab Tiuxetan
n=41 participants at risk
Patients receive rituximab IV followed by indium In-111 ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. Patients undergo APBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO and sirolimus PO beginning on day -3 and continuing for up to 6 months with taper.
rituximab: Given IV fludarabine phosphate: Given IV melphalan: Given IV sirolimus: Given PO tacrolimus: Given PO or IV allogeneic hematopoietic stem cell transplantation: Undergo APBSCT indium In 111 ibritumomab tiuxetan: Given IV yttrium Y 90 ibritumomab tiuxetan: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Bone marrow cellularity
|
34.1%
14/41 • Number of events 20 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
DIC (disseminated intravascular coagulation)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Edema:head and neck
|
46.3%
19/41 • Number of events 21 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Edema:limb
|
85.4%
35/41 • Number of events 51 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Edema:trunk/genital
|
12.2%
5/41 • Number of events 5 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Haptoglobin
|
12.2%
5/41 • Number of events 5 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Hematoma
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
41/41 • Number of events 126 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
|
17.1%
7/41 • Number of events 9 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Hemorrhage, GI
|
53.7%
22/41 • Number of events 31 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Hemorrhage, GU
|
48.8%
20/41 • Number of events 24 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Hemorrhage, pulmonary/upper respiratory
|
48.8%
20/41 • Number of events 22 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding - Other (Specify, __)
|
7.3%
3/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
INR (International Normalized Ratio of prothrombin time)
|
7.3%
3/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Iron overload
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
100.0%
41/41 • Number of events 114 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Lymphatics - Other (Specify, __)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
41/41 • Number of events 143 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
100.0%
41/41 • Number of events 142 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
14.6%
6/41 • Number of events 7 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
34.1%
14/41 • Number of events 15 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Phlebitis (including superficial thrombosis)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Platelets
|
100.0%
41/41 • Number of events 103 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Thrombosis/embolism (vascular access-related)
|
7.3%
3/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Thrombosis/thrombus/embolism
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
24.4%
10/41 • Number of events 12 • From initial treatment to off study, up to 5 years.
|
|
Cardiac disorders
Cardiac General - Other (Specify, __)
|
7.3%
3/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Cardiac disorders
Conduction abnormality/atrioventricular heart block
|
2.4%
1/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Cardiac disorders
Hypertension
|
73.2%
30/41 • Number of events 79 • From initial treatment to off study, up to 5 years.
|
|
Cardiac disorders
Hypotension
|
39.0%
16/41 • Number of events 19 • From initial treatment to off study, up to 5 years.
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
14.6%
6/41 • Number of events 7 • From initial treatment to off study, up to 5 years.
|
|
Cardiac disorders
Palpitations
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
7.3%
3/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Cardiac disorders
Pericarditis
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Cardiac disorders
Prolonged QTc interval
|
26.8%
11/41 • Number of events 15 • From initial treatment to off study, up to 5 years.
|
|
Cardiac disorders
Pulmonary hypertension
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
73.2%
30/41 • Number of events 59 • From initial treatment to off study, up to 5 years.
|
|
Cardiac disorders
Ventricular arrhythmia
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Ear and labyrinth disorders
Hearing
|
4.9%
2/41 • Number of events 4 • From initial treatment to off study, up to 5 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Endocrine disorders
Cushingoid appearance
|
24.4%
10/41 • Number of events 11 • From initial treatment to off study, up to 5 years.
|
|
Endocrine disorders
Hot flashes/flushes
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Endocrine disorders
Neuroendocrine:ADH secretion abnormality (e.g., SIADH or low ADH)
|
4.9%
2/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Endocrine disorders
Pancreatic endocrine: glucose intolerance
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Eye disorders
Cataract
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Eye disorders
Dry eye syndrome
|
14.6%
6/41 • Number of events 7 • From initial treatment to off study, up to 5 years.
|
|
Eye disorders
Glaucoma
|
2.4%
1/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Eye disorders
Nystagmus
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Eye disorders
Ocular surface disease
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Eye disorders
Ocular/Visual - Other (Specify, __)
|
4.9%
2/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Eye disorders
Ophthalmoplegia/diplopia (double vision)
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Eye disorders
Proptosis/enophthalmos
|
2.4%
1/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Eye disorders
Vision-blurred vision
|
9.8%
4/41 • Number of events 4 • From initial treatment to off study, up to 5 years.
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Anorexia
|
85.4%
35/41 • Number of events 51 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
14.6%
6/41 • Number of events 8 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Colitis
|
12.2%
5/41 • Number of events 5 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Constipation
|
43.9%
18/41 • Number of events 19 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Dehydration
|
26.8%
11/41 • Number of events 11 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Dental: teeth
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
41/41 • Number of events 78 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
51.2%
21/41 • Number of events 26 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
75.6%
31/41 • Number of events 32 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
17.1%
7/41 • Number of events 8 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Esophagitis
|
14.6%
6/41 • Number of events 6 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
24.4%
10/41 • Number of events 10 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __)
|
14.6%
6/41 • Number of events 6 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
51.2%
21/41 • Number of events 28 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Hemorrhoids
|
24.4%
10/41 • Number of events 11 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
12.2%
5/41 • Number of events 5 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
97.6%
40/41 • Number of events 75 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
87.8%
36/41 • Number of events 57 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
41/41 • Number of events 61 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Proctitis
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Salivary gland changes/saliva
|
7.3%
3/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Stricture/stenosis (including anastomotic), GI
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
22.0%
9/41 • Number of events 11 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Ulcer, GI
|
12.2%
5/41 • Number of events 5 • From initial treatment to off study, up to 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
90.2%
37/41 • Number of events 45 • From initial treatment to off study, up to 5 years.
|
|
General disorders
Constitutional Symptoms - Other (Specify, __)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
100.0%
41/41 • Number of events 93 • From initial treatment to off study, up to 5 years.
|
|
General disorders
Fever
|
34.1%
14/41 • Number of events 15 • From initial treatment to off study, up to 5 years.
|
|
General disorders
Insomnia
|
75.6%
31/41 • Number of events 39 • From initial treatment to off study, up to 5 years.
|
|
General disorders
Pain
|
97.6%
40/41 • Number of events 463 • From initial treatment to off study, up to 5 years.
|
|
General disorders
Pain - Other (Specify, __)
|
36.6%
15/41 • Number of events 21 • From initial treatment to off study, up to 5 years.
|
|
General disorders
Rigors/chills
|
68.3%
28/41 • Number of events 32 • From initial treatment to off study, up to 5 years.
|
|
General disorders
Sweating (diaphoresis)
|
22.0%
9/41 • Number of events 10 • From initial treatment to off study, up to 5 years.
|
|
General disorders
Weight gain
|
61.0%
25/41 • Number of events 26 • From initial treatment to off study, up to 5 years.
|
|
General disorders
Weight loss
|
75.6%
31/41 • Number of events 64 • From initial treatment to off study, up to 5 years.
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Hepatobiliary disorders
Pancreatitis
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
7.3%
3/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Immune system disorders
Autoimmune reaction
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
24.4%
10/41 • Number of events 13 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Febrile neutropenia
|
63.4%
26/41 • Number of events 26 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
|
48.8%
20/41 • Number of events 30 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Infection - Other (Specify, __)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
70.7%
29/41 • Number of events 77 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Infection with unknown ANC
|
9.8%
4/41 • Number of events 4 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Infection, Bacterial
|
36.6%
15/41 • Number of events 27 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Infection, Fungal
|
7.3%
3/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Infection, Viral
|
36.6%
15/41 • Number of events 21 • From initial treatment to off study, up to 5 years.
|
|
Infections and infestations
Opportunistic infection associated with >=Grade 2 Lymphopenia
|
2.4%
1/41 • Number of events 4 • From initial treatment to off study, up to 5 years.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
85.4%
35/41 • Number of events 65 • From initial treatment to off study, up to 5 years.
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
92.7%
38/41 • Number of events 71 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Acidosis (metabolic or respiratory)
|
7.3%
3/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Albumin, serum-low (hypoalbuminemia)
|
97.6%
40/41 • Number of events 71 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Alkaline phosphatase
|
56.1%
23/41 • Number of events 44 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Alkalosis (metabolic or respiratory)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Amylase
|
4.9%
2/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Bicarbonate, serum-low
|
70.7%
29/41 • Number of events 39 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
36.6%
15/41 • Number of events 18 • From initial treatment to off study, up to 5 years.
|
|
Investigations
CPK (creatine phosphokinase)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Calcium, serum-high (hypercalcemia)
|
22.0%
9/41 • Number of events 10 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Calcium, serum-low (hypocalcemia)
|
87.8%
36/41 • Number of events 50 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Cholesterol, serum-high (hypercholesteremia)
|
68.3%
28/41 • Number of events 48 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Creatinine
|
58.5%
24/41 • Number of events 36 • From initial treatment to off study, up to 5 years.
|
|
Investigations
GGT (gamma-Glutamyl transpeptidase)
|
7.3%
3/41 • Number of events 5 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Glucose, serum-high (hyperglycemia)
|
95.1%
39/41 • Number of events 85 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Glucose, serum-low (hypoglycemia)
|
39.0%
16/41 • Number of events 20 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Hemoglobinuria
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Lipase
|
2.4%
1/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Magnesium, serum-high (hypermagnesemia)
|
24.4%
10/41 • Number of events 11 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Magnesium, serum-low (hypomagnesemia)
|
97.6%
40/41 • Number of events 63 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Phosphate, serum-low (hypophosphatemia)
|
73.2%
30/41 • Number of events 52 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Potassium, serum-high (hyperkalemia)
|
31.7%
13/41 • Number of events 15 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Potassium, serum-low (hypokalemia)
|
95.1%
39/41 • Number of events 73 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Proteinuria
|
24.4%
10/41 • Number of events 11 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Sodium, serum-high (hypernatremia)
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Sodium, serum-low (hyponatremia)
|
92.7%
38/41 • Number of events 74 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Triglyceride, serum-high (hypertriglyceridemia)
|
95.1%
39/41 • Number of events 86 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Uric acid, serum-high (hyperuricemia)
|
14.6%
6/41 • Number of events 7 • From initial treatment to off study, up to 5 years.
|
|
Metabolism and nutrition disorders
Obesity
|
73.2%
30/41 • Number of events 126 • From initial treatment to off study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Extremity-lower (gait/walking)
|
2.4%
1/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
7.3%
3/41 • Number of events 5 • From initial treatment to off study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Joint-effusion
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
90.2%
37/41 • Number of events 79 • From initial treatment to off study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis (avascular necrosis)
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy - possibly related to cancer treatment (Specify, __)
|
4.9%
2/41 • Number of events 7 • From initial treatment to off study, up to 5 years.
|
|
Nervous system disorders
Cognitive disturbance
|
7.3%
3/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Nervous system disorders
Confusion
|
17.1%
7/41 • Number of events 9 • From initial treatment to off study, up to 5 years.
|
|
Nervous system disorders
Dizziness
|
48.8%
20/41 • Number of events 26 • From initial treatment to off study, up to 5 years.
|
|
Nervous system disorders
Encephalopathy
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
19.5%
8/41 • Number of events 9 • From initial treatment to off study, up to 5 years.
|
|
Nervous system disorders
Mental status
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Nervous system disorders
Mood alteration
|
75.6%
31/41 • Number of events 80 • From initial treatment to off study, up to 5 years.
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
7.3%
3/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Nervous system disorders
Neuropathy: cranial
|
4.9%
2/41 • Number of events 6 • From initial treatment to off study, up to 5 years.
|
|
Nervous system disorders
Neuropathy: motor
|
7.3%
3/41 • Number of events 4 • From initial treatment to off study, up to 5 years.
|
|
Nervous system disorders
Neuropathy: sensory
|
53.7%
22/41 • Number of events 26 • From initial treatment to off study, up to 5 years.
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
9.8%
4/41 • Number of events 4 • From initial treatment to off study, up to 5 years.
|
|
Nervous system disorders
Seizure
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
19.5%
8/41 • Number of events 9 • From initial treatment to off study, up to 5 years.
|
|
Nervous system disorders
Syncope (fainting)
|
9.8%
4/41 • Number of events 4 • From initial treatment to off study, up to 5 years.
|
|
Nervous system disorders
Tremor
|
24.4%
10/41 • Number of events 10 • From initial treatment to off study, up to 5 years.
|
|
Renal and urinary disorders
Bladder spasms
|
7.3%
3/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Renal and urinary disorders
Cystitis
|
9.8%
4/41 • Number of events 4 • From initial treatment to off study, up to 5 years.
|
|
Renal and urinary disorders
Incontinence, urinary
|
7.3%
3/41 • Number of events 3 • From initial treatment to off study, up to 5 years.
|
|
Renal and urinary disorders
Obstruction, GU
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Renal and urinary disorders
Renal failure
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
19.5%
8/41 • Number of events 9 • From initial treatment to off study, up to 5 years.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
9.8%
4/41 • Number of events 4 • From initial treatment to off study, up to 5 years.
|
|
Renal and urinary disorders
Urine color change
|
9.8%
4/41 • Number of events 4 • From initial treatment to off study, up to 5 years.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Reproductive system and breast disorders
Libido
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
46.3%
19/41 • Number of events 24 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
17.1%
7/41 • Number of events 7 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Carbon monoxide diffusion capacity (DL(co))
|
73.2%
30/41 • Number of events 35 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
51.2%
21/41 • Number of events 31 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
48.8%
20/41 • Number of events 34 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Edema, larynx
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
FEV(1)
|
31.7%
13/41 • Number of events 16 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
14.6%
6/41 • Number of events 6 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
24.4%
10/41 • Number of events 17 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
4.9%
2/41 • Number of events 4 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
48.8%
20/41 • Number of events 27 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
41.5%
17/41 • Number of events 25 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
58.5%
24/41 • Number of events 36 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Vital capacity
|
22.0%
9/41 • Number of events 11 • From initial treatment to off study, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
14.6%
6/41 • Number of events 7 • From initial treatment to off study, up to 5 years.
|
|
Investigations
Syndromes - Other (Specify, __)
|
31.7%
13/41 • Number of events 13 • From initial treatment to off study, up to 5 years.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
43.9%
18/41 • Number of events 20 • From initial treatment to off study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Burn
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
17.1%
7/41 • Number of events 11 • From initial treatment to off study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
36.6%
15/41 • Number of events 17 • From initial treatment to off study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
39.0%
16/41 • Number of events 18 • From initial treatment to off study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
56.1%
23/41 • Number of events 33 • From initial treatment to off study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
26.8%
11/41 • Number of events 14 • From initial treatment to off study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Induration/fibrosis (skin and subcutaneous tissue)
|
2.4%
1/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
41.5%
17/41 • Number of events 21 • From initial treatment to off study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
95.1%
39/41 • Number of events 60 • From initial treatment to off study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
19.5%
8/41 • Number of events 11 • From initial treatment to off study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
2.4%
1/41 • Number of events 1 • From initial treatment to off study, up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
4.9%
2/41 • Number of events 2 • From initial treatment to off study, up to 5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place