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).

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Weekly during treatment and continuing up through Day 90

Results posted on

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

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

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

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 90

Population: 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

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 90

Population: 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

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 months

Population: 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

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 treatment

Population: 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 4

Population: 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

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

2.5 mg/kg MGd & 6-24% Bone Marrow Involvement

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement

Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths

5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement

Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths

3.5 mg/kg MGd & 6-24% Bone Marrow Involvement

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

5.0 mg/kg MGd & 6-24% Bone Marrow Involvement

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

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

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

Phone: 312-695-1301

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place