Trial Outcomes & Findings for Iodine-131 Anti-B1 Antibody Consolidation for Patients With Non-Hodgkin's Lymphoma Following First-line CHOP (NCT NCT01868035)
NCT ID: NCT01868035
Last Updated: 2017-01-09
Results Overview
Hematology parameter grades were summarized according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 2.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included absolute neutrophil count (ANC) (calculated) \<1000 cells/millimeters cubed (mm\^3), white blood cells (WBC) \<2000 cells/mm\^3, platelets \<50000 cells/mm\^3, and hemoglobin \< 8.0 grams/deciliter.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
From Baseline until Week 25 and follow-up (up to 130 months)
Results posted on
2017-01-09
Participant Flow
All participants were treated with 6 to 8 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy, and were required to have a response (complete response \[CR\], complete response unconfirmed \[CRu\], partial response \[PR\]) to be eligible for Tositumomab and iodine I 131 tositumomab (TST/I 131 TST) therapy.
Participant milestones
| Measure |
TST/Iodine I-131 TST
Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
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|---|---|
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Overall Study
STARTED
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15
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Overall Study
COMPLETED
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8
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Overall Study
NOT COMPLETED
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7
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Reasons for withdrawal
| Measure |
TST/Iodine I-131 TST
Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
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Overall Study
Lost to Follow-up
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3
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Overall Study
Withdrawal by Subject
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1
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Overall Study
Progressive Disease
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2
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Overall Study
Non-compliance
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1
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Baseline Characteristics
Iodine-131 Anti-B1 Antibody Consolidation for Patients With Non-Hodgkin's Lymphoma Following First-line CHOP
Baseline characteristics by cohort
| Measure |
TST/Iodine I-131 TST
n=15 Participants
Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
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Age, Continuous
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51.8 Years
STANDARD_DEVIATION 13.9 • n=5 Participants
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Gender
Female
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9 Participants
n=5 Participants
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Gender
Male
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6 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
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13 participants
n=5 Participants
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Race/Ethnicity, Customized
Hispanic
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1 participants
n=5 Participants
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Race/Ethnicity, Customized
Asian
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1 participants
n=5 Participants
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PRIMARY outcome
Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)Population: Intent-to-treat (ITT) Population: all participants who received study drug
Hematology parameter grades were summarized according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 2.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included absolute neutrophil count (ANC) (calculated) \<1000 cells/millimeters cubed (mm\^3), white blood cells (WBC) \<2000 cells/mm\^3, platelets \<50000 cells/mm\^3, and hemoglobin \< 8.0 grams/deciliter.
Outcome measures
| Measure |
TST/Iodine I-131 TST
n=15 Participants
Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
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Number of Participants With the Indicated Grade 4 Hematology Toxicities Following Iodine-131 Anti-B1 Antibody
ANC (calculated)
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1 participants
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Number of Participants With the Indicated Grade 4 Hematology Toxicities Following Iodine-131 Anti-B1 Antibody
WBC count
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1 participants
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Number of Participants With the Indicated Grade 4 Hematology Toxicities Following Iodine-131 Anti-B1 Antibody
Platelet count
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1 participants
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Number of Participants With the Indicated Grade 4 Hematology Toxicities Following Iodine-131 Anti-B1 Antibody
Hemoglobin
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1 participants
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SECONDARY outcome
Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)Population: ITT Population. A con. CR+CRu requires that the best response be con. by the same response or better \>=4 weeks apart. The individual rows for con. CR, CRu, and PR represent par. with the best response con. by the same exact response. One par. in the CR+CRu category is not counted in the con. CR category because the CR was not con. by another CR.
CR is defined as the complete disappearance of all detectable clinical/radiographic evidence of disease, the disappearance of all disease-related symptoms if present before therapy, and normalization of biochemical abnormalities definitely assignable to non Hodgkin's lymphoma (NHL). PR is defined as a \>=50% decrease in the sum of perpendicular diameters (SPPD) of splenic and hepatic nodules determined at Baseline. SD is defined as less than a PR, but not PD, which is defined as a \>=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was \>1.5 centimeters (cm) by radiographic evaluation or \>1.0 cm by physical examination. RD is defined as the appearance of any new lesion or an increase of \>= 50% in the size of nodules. Confirmed response requires that the same or better response be confirmed by two consecutive post-therapy response evaluations at least 4 weeks apart.
Outcome measures
| Measure |
TST/Iodine I-131 TST
n=15 Participants
Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
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Number of Participants (Par.) With Confirmed (Con.) Complete Response (CR) Confirmed, Confirmed Complete Response Unconfirmed (CRu), Confirmed Partial Response (PR), Relapse Disease (RD), and Progressive Disease (PD)
CR
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12 participants
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Number of Participants (Par.) With Confirmed (Con.) Complete Response (CR) Confirmed, Confirmed Complete Response Unconfirmed (CRu), Confirmed Partial Response (PR), Relapse Disease (RD), and Progressive Disease (PD)
CRu
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0 participants
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Number of Participants (Par.) With Confirmed (Con.) Complete Response (CR) Confirmed, Confirmed Complete Response Unconfirmed (CRu), Confirmed Partial Response (PR), Relapse Disease (RD), and Progressive Disease (PD)
CR + CRu
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13 participants
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Number of Participants (Par.) With Confirmed (Con.) Complete Response (CR) Confirmed, Confirmed Complete Response Unconfirmed (CRu), Confirmed Partial Response (PR), Relapse Disease (RD), and Progressive Disease (PD)
PR
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1 participants
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Number of Participants (Par.) With Confirmed (Con.) Complete Response (CR) Confirmed, Confirmed Complete Response Unconfirmed (CRu), Confirmed Partial Response (PR), Relapse Disease (RD), and Progressive Disease (PD)
SD
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0 participants
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Number of Participants (Par.) With Confirmed (Con.) Complete Response (CR) Confirmed, Confirmed Complete Response Unconfirmed (CRu), Confirmed Partial Response (PR), Relapse Disease (RD), and Progressive Disease (PD)
PD
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0 participants
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SECONDARY outcome
Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)Population: ITT Population. Only those participants with a confirmed response were analyzed. Duration measures were calculated using Kaplan-Meier techniques.
Duration of response for all participants with confirmed PR, confirmed CRu, or confirmed CR is defined as the time from the first documented response to the first documented progression. CR is defined as the complete disappearance of all detectable clinical/radiographic evidence of disease, the disappearance of all disease-related symptoms if present before therapy, and the normalization of biochemical abnormalities definitely assignable to NHL. PR is defined as a \>=50% decrease in the sum of the perpendicular diameters (SPPD) of splenic and hepatic nodules determined at Baseline. PD is defined as a \>=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was \>1.5 centimeters (cm) by radiographic evaluation or \>1.0 cm by physical examination. Confirmed response requires that the same or better response be confirmed by two consecutive post-therapy response evaluations at least 4 weeks apart.
Outcome measures
| Measure |
TST/Iodine I-131 TST
n=14 Participants
Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
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Duration of Response and Duration of Confirmed Complete Response
All confirmed responders, n=14
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58.4 months
Interval 12.0 to
The SAS procedure was not able to calculate the upper limit of the confidence interval due to the low number of events.
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Duration of Response and Duration of Confirmed Complete Response
Confirmed complete responders, n=12
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58.4 months
Interval 20.9 to
The SAS procedure was not able to calculate the upper limit of the confidence interval due to the low number of events.
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SECONDARY outcome
Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)Population: ITT Population
PFS is defined as the time from the start of treatment to the first documented progression or death. Duration measures were calculated using Kaplan-Meier techniques. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator. PD is defined as a \>=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was \>1.5 centimeters (cm) by radiographic evaluation or \>1.0 cm by physical examination.
Outcome measures
| Measure |
TST/Iodine I-131 TST
n=15 Participants
Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
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Progression-free Survival (PFS)
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63.0 months
Interval 16.1 to
The SAS procedure was not able to calculate the upper limit of the confidence interval due to the low number of events.
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SECONDARY outcome
Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)Population: ITT Population
TTF is defined as the time from the start of treatment to the first occurrence of treatment withdrawal, decision to seek additional therapy, study removal, disease progression, or death. Duration measures were calculated using Kaplan-Meier techniques. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator. PD is defined as a \>=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was \>1.5 centimeters (cm) by radiographic evaluation or \>1.0 cm by physical examination.
Outcome measures
| Measure |
TST/Iodine I-131 TST
n=15 Participants
Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
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Time to Treatment Failure (TTF)
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63.0 months
Interval 16.1 to
The SAS procedure was not able to calculate the upper limit of the confidence interval due to the low number of events.
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SECONDARY outcome
Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)Population: ITT Population
TBRT is the time at which the activity of infusion is 37% of that at time zero. Whole body images from anterior and posterior gamma camera scans were collected to assess dosimetry. The assessment of organ dosimetry required gamma camera scans from at least 4 time points. Nuclear medicine reviewers conducted a visual examination of the gamma camera scans and calculated the TBRTs. Residence time is calculated from the rate of total body clearance of iodine I-131 radioactivity during the dosimetric dose. Residence time is a measure of how long the drug resides in the body.
Outcome measures
| Measure |
TST/Iodine I-131 TST
n=15 Participants
Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
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Total Body Residence Time (TBRT)
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105.5 hours
Standard Deviation 11.55
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SECONDARY outcome
Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)Population: ITT Population
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily have to have a casual relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or significant worsening of a pre-existing sign or symptom, or disease temporally associated with the use of a medicinal product. An SAE is defined as any experience occurring at any dose that results in the following outcomes: death, a life-threatening adverse experience, in-patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. See the SAE/AE module for a complete list of SAEs/AEs.
Outcome measures
| Measure |
TST/Iodine I-131 TST
n=15 Participants
Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
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Number of Participants With an Adverse Experience, Including Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
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14 participants
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Number of Participants With an Adverse Experience, Including Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE
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3 participants
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SECONDARY outcome
Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)Population: ITT Population
Hematology toxicities included ANC (calculated), WBC count, platelet count, and hemoglobin. Time to recovery to Baseline grade for participants with Grade 0 toxicity at Baseline was defined as the time from the date of the last administration of study drug to the first post-nadir date with Grade 0 toxicity, with no other Grade 1-4 toxicities recorded during the next week. For participants with a Grade 1-4 toxicity at Baseline, time to recovery was defined as the time from the last administration of study drug to the first post-nadir date with a Baseline grade or better, with no other higher grade toxicities recorded during the next week. For participants with a nadir grade less than or equal to the Baseline grade, the time to recovery to the Baseline grade equaled the time to nadir.
Outcome measures
| Measure |
TST/Iodine I-131 TST
n=15 Participants
Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
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Time to Recovery From the Indicated Hematology Toxicities
ANC (calculated)
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78.5 days
Interval 57.0 to 90.0
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Time to Recovery From the Indicated Hematology Toxicities
Hemoglobin
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69.0 days
Interval 41.0 to 167.0
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Time to Recovery From the Indicated Hematology Toxicities
Platelet count
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51.0 days
Interval 43.0 to 70.0
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Time to Recovery From the Indicated Hematology Toxicities
WBC count
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77.0 days
Interval 71.0 to 91.0
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SECONDARY outcome
Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)Population: ITT Population
Hematology toxicities included ANC (calculated), hemoglobin, platelet count, WBC count. Nadir is defined as lowest counts that the cells reach after chemotherapy.
Outcome measures
| Measure |
TST/Iodine I-131 TST
n=15 Participants
Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
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Nadir for the Indicated Hematology Toxicities
Nadir, Baseline, Hemoglobin
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10.5 10^3 cells/millimeters cubed (mm^3)
Standard Deviation 2.37
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Nadir for the Indicated Hematology Toxicities
Nadir, Baseline, ANC
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1.1 10^3 cells/millimeters cubed (mm^3)
Standard Deviation 0.47
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Nadir for the Indicated Hematology Toxicities
Nadir, Baseline, platelet count
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89.9 10^3 cells/millimeters cubed (mm^3)
Standard Deviation 45.85
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Nadir for the Indicated Hematology Toxicities
Nadir, Baseline, WBC count
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2.2 10^3 cells/millimeters cubed (mm^3)
Standard Deviation 0.70
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SECONDARY outcome
Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)Population: ITT Population
Hematology toxicities included ANC (calculated), WBC count, platelet count, and hemoglobin. Nadir is defined as the lowest counts (for ANC, WBC, and platelet counts)/concentration (for hemoglobin) that the cells reach after chemotherapy. Time to nadir is defined as the time from Baseline to the lowest value recorded up to 120 days following the therapeutic dose.
Outcome measures
| Measure |
TST/Iodine I-131 TST
n=15 Participants
Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
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|---|---|
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Time to Nadir for the Indicated Hematology Toxicities
Time to nadir, ANC
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55.0 days
Standard Deviation 16.52
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Time to Nadir for the Indicated Hematology Toxicities
Time to nadir, Hemoglobin
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49.5 days
Standard Deviation 27.53
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Time to Nadir for the Indicated Hematology Toxicities
Time to nadir, Platelet count
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35.5 days
Standard Deviation 6.94
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Time to Nadir for the Indicated Hematology Toxicities
Time to nadir, WBC count
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52.7 days
Standard Deviation 16.28
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SECONDARY outcome
Timeframe: Week 7 and Week 13Population: ITT Population
During the administration of unlabeled Anti-B1 antibody and Iodine-131 Anti-B1 antibody, emergency support for anaphylaxis, including epinephrine, diphenhydramine, hydrocortisone, a laryngoscope, and an endotracheal tube, was readily available. The use of steroids were discouraged unless other measures were ineffective.
Outcome measures
| Measure |
TST/Iodine I-131 TST
n=15 Participants
Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
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Number of Participants Needing Supportive Care at Week 7 and Week 13
Week 7, any supportive care
|
3 participants
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Number of Participants Needing Supportive Care at Week 7 and Week 13
Week 13, any supportive care
|
3 participants
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SECONDARY outcome
Timeframe: Baseline; any follow-up visit (up to 72 months)Population: ITT Population
The number of participants who developed human anti-murine (mouse) anibodies (HAMA) after treatment was measured.
Outcome measures
| Measure |
TST/Iodine I-131 TST
n=15 Participants
Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
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|---|---|
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Number of Participants Converting to Human Anti-Murine (Mouse) Antibody (HAMA) Positivity at Any Follow-up Visit From HAMA Negativity at Baseline
Positive
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1 participants
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Number of Participants Converting to Human Anti-Murine (Mouse) Antibody (HAMA) Positivity at Any Follow-up Visit From HAMA Negativity at Baseline
Negative
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14 participants
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SECONDARY outcome
Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)Population: ITT Population
Overall survival (time to death) is defined from the start of treatment to the date of death from any cause.
Outcome measures
| Measure |
TST/Iodine I-131 TST
n=15 Participants
Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
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|---|---|
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Overall Survival
|
NA months
Median overall survival could not be estimated by the Kaplan-Meier method because the median was not reached.
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Adverse Events
TST/Iodine I-131 TST
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TST/Iodine I-131 TST
n=15 participants at risk
Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
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|---|---|
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
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6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Nervous system disorders
Central nervous system lesion
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
Other adverse events
| Measure |
TST/Iodine I-131 TST
n=15 participants at risk
Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
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|---|---|
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General disorders
Fatigue
|
73.3%
11/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
General disorders
Pyrexia
|
13.3%
2/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
General disorders
Asthenia
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
General disorders
Chest discomfort
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
General disorders
Chest pain
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
General disorders
Chills
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
General disorders
Local swelling
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
General disorders
Oedema
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
General disorders
Oedema peripheral
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Investigations
ANC (calc) < 1,000 cells/mm3
|
46.7%
7/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Investigations
WBC < 2,000 cells/mm3
|
40.0%
6/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Investigations
Platelets <50,000 cells/mm3
|
26.7%
4/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Investigations
Hemoglobin <8.0 gm/dL
|
20.0%
3/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
26.7%
4/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
3/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Nervous system disorders
Headache
|
26.7%
4/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Nervous system disorders
Paraesthesia
|
20.0%
3/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Nervous system disorders
Somnolence
|
13.3%
2/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Nervous system disorders
Burning sensation
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Nervous system disorders
Central nervous system lesion
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Nervous system disorders
Sinus headache
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
26.7%
4/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.3%
2/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.3%
2/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.3%
2/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Gastrointestinal disorders
Oral pain
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
3/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Infections and infestations
Candidiasis
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Congenital, familial and genetic disorders
Fungal infection
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Infections and infestations
Herpes zoster
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Infections and infestations
Oral candidiasis
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Infections and infestations
Rhinitis
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
3/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
2/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Investigations
Blood pressure decreased
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Investigations
Blood urine present
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.3%
2/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Eye disorders
Lacrimation increased
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Eye disorders
Ocular hyperaemia
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Psychiatric disorders
Affect lability
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Renal and urinary disorders
Dysuria
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
6.7%
1/15 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 130 months).
An on-therapy AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants who received study drug.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER