Trial Outcomes & Findings for Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20+ NHL (NCT NCT00089284)
NCT ID: NCT00089284
Last Updated: 2019-08-14
Results Overview
The number of Dose Limiting Toxicities (DLT) observed in patients treated with Motexafin Gadolinium at different dose levels in combination with Rituxan, Indium-Zevalin, and 90Yttrium-Zevalin was used to determine the Maximum Tolerated Dose (MTD) to be used for phase II of the study. The number of dose-limiting toxicities observed in each cohort of patients determined whether to continue dose escalation. Each cohort = at least 3 patients. All toxicities will be graded according to the NCI Common Toxicity Criteria, version 2.0, with a DLT defined as any of the following: Grade 3 or 4 non-hematologic toxicity (other than grade 3 nausea or vomiting). Grade 4 vomiting despite maximal antiemetic support. Grade 4 neutropenia and thrombocytopenia either lasting longer than 14 days-Grade 4 duration will be measured (in days) from the first date in grade 4 to last date in grade 4 after nadir (growth factor and transfusion independent, respectively).
TERMINATED
PHASE1/PHASE2
30 participants
Weekly during treatment and continuing up through Day 90
2019-08-14
Participant Flow
The study was open to accrual between the dates of September 10, 2003 and October 31, 2007 with the first patient enrolled on study October 28, 2003. Patients were recruited from the outpatient Hematology-Oncology clinic at Northwestern Medical Faculty Foundation, and the in-patient Hematology-Oncology service of Northwestern Memorial Hospital.
For phase I, patients were allocated according to the amount of bone marrow involvement they expressed (either ≤ 5% or ≤ 6-24% involvement). Initially, patients were accrued to the first cohort of the ≤ 5% involvement group. After that group moved to the second cohort, patients in the ≤ 6-24% involvement group were enrolled to the first cohort.
Participant milestones
| Measure |
Phase I: 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement
For the phase I dose-escalation portion, patients were allocated based on the amount of lymphoma bone marrow involvement. Initially, enrollment to the first cohort (2.5 mg/kg MGd) was open only to those with ≤ 5% of bone marrow involvement.
|
Phase I: 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement
In the phase I portion of the study, following completion of enrollment of patients with ≤ 5% bone marrow involvement to their first cohort (2.5 mg/kg MGd), patients with 6-24% bone marrow involvement could be enrolled to their first cohort (2.5 mg/kg MGd).
|
Phase I: 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement
After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd).
|
Phase I: 5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement
After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd).
|
Phase I: 3.5 mg/kg MGd & 6-24% Bone Marrow Involvement
After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 6-24% Bone Marrow Involvement group, patients with ≤ 6-24% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd).
|
Phase I: 5.0 mg/kg MGd & 6-24% Bone Marrow Involvement
After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 6-24% Bone Marrow Involvement group, patients with ≤ 6-24% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd).
|
Phase II: 5.0 mg/kg MGd & </= 5% Bone Marrow Involvement
After completion of the Phase I portion, patients were enrolled to the maximum tolerated dose (MTD) group of 5.0 mg/kg MGd for \</+ 5% Bone Marrow Involvement.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
6
|
6
|
0
|
0
|
8
|
|
Overall Study
COMPLETED
|
7
|
3
|
6
|
6
|
0
|
0
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Phase I: 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement
For the phase I dose-escalation portion, patients were allocated based on the amount of lymphoma bone marrow involvement. Initially, enrollment to the first cohort (2.5 mg/kg MGd) was open only to those with ≤ 5% of bone marrow involvement.
|
Phase I: 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement
In the phase I portion of the study, following completion of enrollment of patients with ≤ 5% bone marrow involvement to their first cohort (2.5 mg/kg MGd), patients with 6-24% bone marrow involvement could be enrolled to their first cohort (2.5 mg/kg MGd).
|
Phase I: 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement
After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd).
|
Phase I: 5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement
After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd).
|
Phase I: 3.5 mg/kg MGd & 6-24% Bone Marrow Involvement
After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 6-24% Bone Marrow Involvement group, patients with ≤ 6-24% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd).
|
Phase I: 5.0 mg/kg MGd & 6-24% Bone Marrow Involvement
After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 6-24% Bone Marrow Involvement group, patients with ≤ 6-24% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd).
|
Phase II: 5.0 mg/kg MGd & </= 5% Bone Marrow Involvement
After completion of the Phase I portion, patients were enrolled to the maximum tolerated dose (MTD) group of 5.0 mg/kg MGd for \</+ 5% Bone Marrow Involvement.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse event before starting treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20+ NHL
Baseline characteristics by cohort
| Measure |
Phase I: 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement
n=7 Participants
For the phase I dose-escalation portion, patients were allocated based on the amount of lymphoma bone marrow involvement. Initially, enrollment to the first cohort (2.5 mg/kg MGd) was open only to those with ≤ 5% of bone marrow involvement.
|
Phase I: 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement
n=3 Participants
In the phase I portion of the study, following completion of enrollment of patients with ≤ 5% bone marrow involvement to their first cohort (2.5 mg/kg MGd), patients with 6-24% bone marrow involvement could be enrolled to their first cohort (2.5 mg/kg MGd).
|
Phase I: 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement
n=6 Participants
After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd).
|
Phase I: 5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement
n=6 Participants
After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd).
|
Phase II: 5.0 mg/kg MGd & </= 5% Bone Marrow Involvement
n=8 Participants
After completion of the Phase I portion, patients were enrolled to the maximum tolerated dose (MTD) group of 5.0 mg/kg MGd for \</+ 5% Bone Marrow Involvement.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
8 participants
n=21 Participants
|
30 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Weekly during treatment and continuing up through Day 90Population: Only patients enrolled during the phase I portion of this trial were analyzed for this outcome measure.
The number of Dose Limiting Toxicities (DLT) observed in patients treated with Motexafin Gadolinium at different dose levels in combination with Rituxan, Indium-Zevalin, and 90Yttrium-Zevalin was used to determine the Maximum Tolerated Dose (MTD) to be used for phase II of the study. The number of dose-limiting toxicities observed in each cohort of patients determined whether to continue dose escalation. Each cohort = at least 3 patients. All toxicities will be graded according to the NCI Common Toxicity Criteria, version 2.0, with a DLT defined as any of the following: Grade 3 or 4 non-hematologic toxicity (other than grade 3 nausea or vomiting). Grade 4 vomiting despite maximal antiemetic support. Grade 4 neutropenia and thrombocytopenia either lasting longer than 14 days-Grade 4 duration will be measured (in days) from the first date in grade 4 to last date in grade 4 after nadir (growth factor and transfusion independent, respectively).
Outcome measures
| Measure |
2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement
n=7 Participants
For the phase I dose-escalation portion, patients were allocated based on the amount of lymphoma bone marrow involvement. Initially, enrollment to the first cohort was open only to those with ≤ 5% of bone marrow involvement.
|
2.5 mg/kg MGd & 6-24% Bone Marrow Involvement
n=3 Participants
In the phase I portion of the study, following completion of enrollment of patients with ≤ 5% bone marrow involvement to the first cohort on the Lesser Bone Marrow Involvement arm, patients with 6-24% bone marrow involvement could be enrolled to the first cohort in the Greater Bone Marrow Involvement arm.
|
3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement
n=6 Participants
Following completion of enrollment to the first cohort, patients with ≤ 5% bone marrow involvement were then enrolled to the second cohort (3.5 mg/kg MGd).
|
5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement
n=6 Participants
Following completion of enrollment to the second cohort, patients with ≤ 5% bone marrow involvement were then enrolled to the third cohort (5.0 mg/kg MGd).
|
3.5 mg/kg MGd & 6-24% Bone Marrow Involvement
Following completion of enrollment to their first cohort, patients with 6-24% bone marrow involvement were then enrolled to their second cohort (3.5 mg/kg MGd).
|
5.0 mg/kg MGd & 6-24% Bone Marrow Involvement
Following completion of enrollment to their second cohort, patients with 6-24% bone marrow involvement were then enrolled to their third cohort (5.0 mg/kg MGd).
|
Phase II: 5.0 mg/kg MGd & </= 5% Bone Marrow Involvement
After completion of the Phase I portion, patients were enrolled to the maximum tolerated dose (MTD) group of 5.0 mg/kg MGd for \</+ 5% Bone Marrow Involvement.
|
|---|---|---|---|---|---|---|---|
|
Dose Limiting Toxicities (DLT)
|
0 Dose-Limiting Toxicities
|
0 Dose-Limiting Toxicities
|
0 Dose-Limiting Toxicities
|
0 Dose-Limiting Toxicities
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Weekly during treatment and continuing up through Day 90Population: Phase I arms were evaluable for this outcome measure.
The maximum tolerated dose (MTD) of Motexafin Gadolinium in combination with Rituxan, Indium-Zevalin, and 90Yttrium-Zevalin was determined using a modified Fibonacci phase I study design (with patient allocation based on amount of lymphoma bone marrow involvement) and will be used in phase II of the study. The MTD will be that dose at which 0/3 or 1/6 patients or 2/9 experience a Dose Limiting Toxicity (DLT), with the next higher dose level provoking DLT in 2/3 or 3/6 or 4/9 patients.
Outcome measures
| Measure |
2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement
n=22 Participants
For the phase I dose-escalation portion, patients were allocated based on the amount of lymphoma bone marrow involvement. Initially, enrollment to the first cohort was open only to those with ≤ 5% of bone marrow involvement.
|
2.5 mg/kg MGd & 6-24% Bone Marrow Involvement
In the phase I portion of the study, following completion of enrollment of patients with ≤ 5% bone marrow involvement to the first cohort on the Lesser Bone Marrow Involvement arm, patients with 6-24% bone marrow involvement could be enrolled to the first cohort in the Greater Bone Marrow Involvement arm.
|
3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement
Following completion of enrollment to the first cohort, patients with ≤ 5% bone marrow involvement were then enrolled to the second cohort (3.5 mg/kg MGd).
|
5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement
Following completion of enrollment to the second cohort, patients with ≤ 5% bone marrow involvement were then enrolled to the third cohort (5.0 mg/kg MGd).
|
3.5 mg/kg MGd & 6-24% Bone Marrow Involvement
Following completion of enrollment to their first cohort, patients with 6-24% bone marrow involvement were then enrolled to their second cohort (3.5 mg/kg MGd).
|
5.0 mg/kg MGd & 6-24% Bone Marrow Involvement
Following completion of enrollment to their second cohort, patients with 6-24% bone marrow involvement were then enrolled to their third cohort (5.0 mg/kg MGd).
|
Phase II: 5.0 mg/kg MGd & </= 5% Bone Marrow Involvement
After completion of the Phase I portion, patients were enrolled to the maximum tolerated dose (MTD) group of 5.0 mg/kg MGd for \</+ 5% Bone Marrow Involvement.
|
|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
5.0 mg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1, 3 and 6 monthsPopulation: All phase I and phase II patients were evaluated for response to treatment (anti-lymphoma efficacy). For the cohort with ≤ 5% bone marrow involvement treated at the 5.0 mg/kg MGd dose, results are based on 6 phase I patients and 8 phase II patients. 2 patients were determined not to be evaluable as they did not reach response time points.
To assess the anti-lymphoma efficacy of the combination of MGd and 90Yttrium-Zevalin therapy. Disease response to treatment was categorized as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or complete response/unconfirmed (CRu). The overall response rate (ORR) was then calculated. The time to treatment failure (TTF), overall survival (OS), and duration of response were determined.
Outcome measures
| Measure |
2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement
n=7 Participants
For the phase I dose-escalation portion, patients were allocated based on the amount of lymphoma bone marrow involvement. Initially, enrollment to the first cohort was open only to those with ≤ 5% of bone marrow involvement.
|
2.5 mg/kg MGd & 6-24% Bone Marrow Involvement
n=3 Participants
In the phase I portion of the study, following completion of enrollment of patients with ≤ 5% bone marrow involvement to the first cohort on the Lesser Bone Marrow Involvement arm, patients with 6-24% bone marrow involvement could be enrolled to the first cohort in the Greater Bone Marrow Involvement arm.
|
3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement
n=5 Participants
Following completion of enrollment to the first cohort, patients with ≤ 5% bone marrow involvement were then enrolled to the second cohort (3.5 mg/kg MGd).
|
5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement
n=13 Participants
Following completion of enrollment to the second cohort, patients with ≤ 5% bone marrow involvement were then enrolled to the third cohort (5.0 mg/kg MGd).
|
3.5 mg/kg MGd & 6-24% Bone Marrow Involvement
Following completion of enrollment to their first cohort, patients with 6-24% bone marrow involvement were then enrolled to their second cohort (3.5 mg/kg MGd).
|
5.0 mg/kg MGd & 6-24% Bone Marrow Involvement
Following completion of enrollment to their second cohort, patients with 6-24% bone marrow involvement were then enrolled to their third cohort (5.0 mg/kg MGd).
|
Phase II: 5.0 mg/kg MGd & </= 5% Bone Marrow Involvement
After completion of the Phase I portion, patients were enrolled to the maximum tolerated dose (MTD) group of 5.0 mg/kg MGd for \</+ 5% Bone Marrow Involvement.
|
|---|---|---|---|---|---|---|---|
|
Anti-lymphoma Efficacy
Complete Response (CR)
|
6 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Anti-lymphoma Efficacy
Partial Response (PR)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Anti-lymphoma Efficacy
Stable Disease (SD)
|
0 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Anti-lymphoma Efficacy
Progressive Disease (PD)
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Anti-lymphoma Efficacy
Complete Response/Uncofirmed (CRu)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline (pre-treatment) and on Day 4 of treatmentPopulation: Data was not collected for analysis of this outcome measure due to lack of funding.
To study the tumor-specific bio-localization of MGd in lymphoma through magnetic resonance imaging (MRI) in a subset of patients. The first 2 patients of each cohort will have MRI imaging to measure if signal intensity, a correlate for MGd uptake, is increased in known areas of lymphomatous involvement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On Day 1 and 4Population: Data not collected for analysis of this outcome measure.
To explore correlative laboratory studies of MGd (ie, uptake of MGd by peripheral mononuclear cells, effect of MGd upon peripheral lymphocyte subset populations).
Outcome measures
Outcome data not reported
Adverse Events
2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement
2.5 mg/kg MGd & 6-24% Bone Marrow Involvement
3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement
5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement
3.5 mg/kg MGd & 6-24% Bone Marrow Involvement
5.0 mg/kg MGd & 6-24% Bone Marrow Involvement
Serious adverse events
| Measure |
2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement
n=7 participants at risk
For the phase I dose-escalation portion, patients were allocated based on the amount of lymphoma bone marrow involvement. Initially, enrollment to the first cohort (2.5 mg/kg MGd) was open only to those with ≤ 5% of bone marrow involvement.
|
2.5 mg/kg MGd & 6-24% Bone Marrow Involvement
n=3 participants at risk
In the phase I portion of the study, following completion of enrollment of patients with ≤ 5% bone marrow involvement to their first cohort (2.5 mg/kg MGd), patients with 6-24% bone marrow involvement could be enrolled to their first cohort (2.5 mg/kg MGd).
|
3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement
n=6 participants at risk
After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd).
|
5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement
n=13 participants at risk
After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd).
|
3.5 mg/kg MGd & 6-24% Bone Marrow Involvement
After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 6-24% Bone Marrow Involvement group, patients with ≤ 6-24% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd).
|
5.0 mg/kg MGd & 6-24% Bone Marrow Involvement
After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 6-24% Bone Marrow Involvement group, patients with ≤ 6-24% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd).
|
|---|---|---|---|---|---|---|
|
General disorders
Death - not otherwise specified
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/13 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Blood and lymphatic system disorders
Death due to disease progression
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Infections and infestations
Febrile neutropenia
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Infections and infestations
Infection with grade 3 or 4 neutrophils
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Renal and urinary disorders
Obstruction, GU: left ureter
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/13 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
Other adverse events
| Measure |
2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement
n=7 participants at risk
For the phase I dose-escalation portion, patients were allocated based on the amount of lymphoma bone marrow involvement. Initially, enrollment to the first cohort (2.5 mg/kg MGd) was open only to those with ≤ 5% of bone marrow involvement.
|
2.5 mg/kg MGd & 6-24% Bone Marrow Involvement
n=3 participants at risk
In the phase I portion of the study, following completion of enrollment of patients with ≤ 5% bone marrow involvement to their first cohort (2.5 mg/kg MGd), patients with 6-24% bone marrow involvement could be enrolled to their first cohort (2.5 mg/kg MGd).
|
3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement
n=6 participants at risk
After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd).
|
5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement
n=13 participants at risk
After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd).
|
3.5 mg/kg MGd & 6-24% Bone Marrow Involvement
After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 6-24% Bone Marrow Involvement group, patients with ≤ 6-24% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd).
|
5.0 mg/kg MGd & 6-24% Bone Marrow Involvement
After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 6-24% Bone Marrow Involvement group, patients with ≤ 6-24% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd).
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
28.6%
2/7 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
38.5%
5/13 • Number of events 5 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Blood and lymphatic system disorders
Anemia
|
71.4%
5/7 • Number of events 5 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
66.7%
4/6 • Number of events 4 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
92.3%
12/13 • Number of events 12 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
15.4%
2/13 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
28.6%
2/7 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
15.4%
2/13 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Metabolism and nutrition disorders
Bilirubin
|
28.6%
2/7 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
30.8%
4/13 • Number of events 4 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Gastrointestinal disorders
Constipation
|
42.9%
3/7 • Number of events 3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
46.2%
6/13 • Number of events 6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Renal and urinary disorders
Creatinine
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Investigations
Cytokine release syndrome (infusion reaction)
|
28.6%
2/7 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
23.1%
3/13 • Number of events 3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Blood and lymphatic system disorders
Dermal change: skin discoloration
|
57.1%
4/7 • Number of events 4 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
83.3%
5/6 • Number of events 5 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
84.6%
11/13 • Number of events 11 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatology - Other: blister
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/13 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
23.1%
3/13 • Number of events 3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/13 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/13 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
2/7 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Blood and lymphatic system disorders
Edema
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
15.4%
2/13 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
FEV1
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/13 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
General disorders
Fatigue
|
57.1%
4/7 • Number of events 4 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
83.3%
5/6 • Number of events 5 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
76.9%
10/13 • Number of events 10 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
General disorders
Fever (in absence of infection)
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/13 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Metabolism and nutrition disorders
GGT
|
57.1%
4/7 • Number of events 4 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
15.4%
2/13 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
15.4%
2/13 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
General disorders
Hemorrhage - gums
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/13 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/13 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
57.1%
4/7 • Number of events 4 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
100.0%
3/3 • Number of events 3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
100.0%
6/6 • Number of events 6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
84.6%
11/13 • Number of events 11 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
42.9%
3/7 • Number of events 3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/13 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Cardiac disorders
Hypertension
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
38.5%
5/13 • Number of events 5 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
28.6%
2/7 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
50.0%
3/6 • Number of events 3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
46.2%
6/13 • Number of events 6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
28.6%
2/7 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
23.1%
3/13 • Number of events 3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
15.4%
2/13 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
28.6%
2/7 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
38.5%
5/13 • Number of events 5 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
28.6%
2/7 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Infections and infestations
Infection
|
57.1%
4/7 • Number of events 4 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
30.8%
4/13 • Number of events 4 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
General disorders
Insomnia
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
15.4%
2/13 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Blood and lymphatic system disorders
Leukocytes
|
100.0%
7/7 • Number of events 7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
100.0%
3/3 • Number of events 3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
83.3%
5/6 • Number of events 5 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
100.0%
13/13 • Number of events 13 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
85.7%
6/7 • Number of events 6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
100.0%
3/3 • Number of events 3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
83.3%
5/6 • Number of events 5 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
92.3%
12/13 • Number of events 12 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Nervous system disorders
Mood alteration - anxiety
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/13 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
53.8%
7/13 • Number of events 7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Blood and lymphatic system disorders
Neutrophils
|
57.1%
4/7 • Number of events 4 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
66.7%
4/6 • Number of events 4 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
84.6%
11/13 • Number of events 11 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
General disorders
Pain - chest/thorax not otherwise specified
|
28.6%
2/7 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/13 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Renal and urinary disorders
Pain - dysuria
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Nervous system disorders
Pain - headache
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Eye disorders
Pain - lacrimal
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain - myalgia
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
15.4%
2/13 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Reproductive system and breast disorders
Pain - pelvic
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/13 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Blood and lymphatic system disorders
Petechiae
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Vascular disorders
Phlebitis
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/13 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Blood and lymphatic system disorders
Platelets
|
100.0%
7/7 • Number of events 7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
100.0%
3/3 • Number of events 3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
83.3%
5/6 • Number of events 5 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
100.0%
13/13 • Number of events 13 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Metabolism and nutrition disorders
Proteinuria
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
23.1%
3/13 • Number of events 3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
15.4%
2/13 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Renal and urinary disorders
Renal - Other (hematuria)
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
General disorders
Sweating
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/13 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Gastrointestinal disorders
Taste alteration
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
15.4%
2/13 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Hepatobiliary disorders
Transaminases - AST/ALT
|
71.4%
5/7 • Number of events 5 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
50.0%
3/6 • Number of events 3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
23.1%
3/13 • Number of events 3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Renal and urinary disorders
Urinary rentention
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/13 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Cardiac disorders
Ventricular tachycardia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
50.0%
3/6 • Number of events 3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
15.4%
2/13 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
Gastrointestinal disorders
Weight gain
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
|
General disorders
Weight loss
|
0.00%
0/7 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/3 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
0.00%
0/6 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
15.4%
2/13 • Number of events 2 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
—
0/0 • Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
|
Additional Information
Clinical Research Office Administrator
Northwestern University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place