Trial Outcomes & Findings for Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis (NCT NCT00104299)
NCT ID: NCT00104299
Last Updated: 2017-04-21
Results Overview
A Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) score of 0 with prednisone taper successfully completed at six months. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
197 participants
Primary outcome timeframe
6 months post-randomization
Results posted on
2017-04-21
Participant Flow
Eight centers in the United States and one center in the Netherlands (Groningen) enrolled 197 Antineutrophil cytoplasmic antibodies (ANCA)-positive patients with either Wegener's granulomatosis or microscopic polyangiitis between December 30, 2004 and June 30, 2008.
At a screening visit, participants underwent procedures to establish inclusion/exclusion criteria and then sign the informed consent form.
Participant milestones
| Measure |
Rituximab
Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
|
Control Group
Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
98
|
|
Overall Study
COMPLETED
|
90
|
88
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
Reasons for withdrawal
| Measure |
Rituximab
Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
|
Control Group
Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
6
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
To have renal transplant
|
1
|
0
|
Baseline Characteristics
Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis
Baseline characteristics by cohort
| Measure |
Rituximab
n=99 Participants
Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
|
Control Group
n=98 Participants
Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 16.8 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 14.1 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
91 participants
n=5 Participants
|
90 participants
n=7 Participants
|
181 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
BVAS/WG
|
8.1 score units
STANDARD_DEVIATION 2.8 • n=5 Participants
|
8.0 score units
STANDARD_DEVIATION 3.4 • n=7 Participants
|
8.0 score units
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
VDI
|
1.4 score units
STANDARD_DEVIATION 1.8 • n=5 Participants
|
1.0 score units
STANDARD_DEVIATION 1.4 • n=7 Participants
|
1.2 score units
STANDARD_DEVIATION 1.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post-randomizationPopulation: Intent-to-treat (ITT) sample with worst case imputation
A Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) score of 0 with prednisone taper successfully completed at six months. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease.
Outcome measures
| Measure |
Rituximab
n=99 Participants
Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
|
Control Group
n=98 Participants
Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
|
|---|---|---|
|
Disease Remission
|
63 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: Through common close-out (defined as 18 months after the last participant is enrolled in the trial)Population: Safety Sample
The adverse event rate for the following events considered related to vasculitis: Death; Grade 2 or higher leukopenia or thrombocytopenia; Grade 3 or higher infections; Hemorrhagic cystitis (grade 2 or lower needs confirmation by cytoscopy); Malignancy; Venous thromboembolic event (deep venous thrombosis or pulmonary embolism); Hospitalization resulting either from the disease or from a complication due to study treatment; Infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions (including cytokine release allergic reaction); Cerebrovascular accident
Outcome measures
| Measure |
Rituximab
n=99 Participants
Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
|
Control Group
n=98 Participants
Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
|
|---|---|---|
|
Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy
Death
|
2 participants
|
2 participants
|
|
Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy
Grade 2 or Higher Leukopenia
|
7 participants
|
23 participants
|
|
Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy
Grade 2 or Higher Thrombocytopenia
|
4 participants
|
1 participants
|
|
Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy
Grade 3 or Higher Infections
|
18 participants
|
16 participants
|
|
Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy
Hemorrhagic Cystitis (Grade 2 or Lower)
|
2 participants
|
1 participants
|
|
Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy
Malignancy
|
5 participants
|
2 participants
|
|
Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy
Venous Thromboembolic Event
|
6 participants
|
8 participants
|
|
Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy
Hospitalization Resulting from the Disease
|
16 participants
|
7 participants
|
|
Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy
Cerebrovascular Accident (CVA)
|
1 participants
|
1 participants
|
|
Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy
Infusion Reactions Leading to Infusion Disc.
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 months post-randomizationPopulation: Safety Sample
The 2-sided 95% CI of the percentage of participants who have a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\[1\] of 0 and have successfully completed the glucocorticoid taper by 6 months post-randomization and the 2-sided 95% CI of the difference between two arms for assessing the superiority of rituximab to control \[1\] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease
Outcome measures
| Measure |
Rituximab
n=99 Participants
Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
|
Control Group
n=98 Participants
Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
|
|---|---|---|
|
Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization
|
62 participants
|
51 participants
|
SECONDARY outcome
Timeframe: 18 months post-randomizationPopulation: Intent-to-treat
Duration of complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\[1\] of 0 and a completing taper of Prednisone to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing. \[1\] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease
Outcome measures
| Measure |
Rituximab
n=99 Participants
Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
|
Control Group
n=98 Participants
Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
|
|---|---|---|
|
The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups
25% Quartile (95%CI)
|
243 Days
Interval 172.0 to
Some survival parameters are not estimable when there are small numbers of events
|
230 Days
Interval 145.0 to
Some survival parameters are not estimable when there are small numbers of events
|
|
The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups
50% Quartile (95%CI)
|
NA Days
Some survival parameters are not estimable when there are small numbers of events
|
NA Days
Some survival parameters are not estimable when there are small numbers of events
|
|
The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups
75% Quartile (95%CI)
|
NA Days
Some survival parameters are not estimable when there are small numbers of events
|
NA Days
Some survival parameters are not estimable when there are small numbers of events
|
SECONDARY outcome
Timeframe: 18 months post-randomizationPopulation: Intent-to-treat
Duration of remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\[1\] of 0 and a completing taper of glucocorticoid by 6 months post-randomization to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing.
Outcome measures
| Measure |
Rituximab
n=99 Participants
Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
|
Control Group
n=98 Participants
Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
|
|---|---|---|
|
The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups
25% Quartile (95%CI)
|
246 Days
Interval 152.0 to 335.0
|
168 Days
Interval 141.0 to 300.0
|
|
The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups
50% Quartile (95%CI)
|
NA Days
Interval 403.0 to
Some survival parameters are not estimable when there are small numbers of events
|
NA Days
Interval 353.0 to
Some survival parameters are not estimable when there are small numbers of events
|
|
The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups
75% Quartile (95%CI)
|
NA Days
Some survival parameters are not estimable when there are small numbers of events
|
NA Days
Some survival parameters are not estimable when there are small numbers of events
|
SECONDARY outcome
Timeframe: 18 months post-randomizationPopulation: Intent-to-treat
Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\[1\] of 0. \[1\] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease
Outcome measures
| Measure |
Rituximab
n=99 Participants
Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
|
Control Group
n=98 Participants
Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
|
|---|---|---|
|
Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups
25% Quartile (95%CI)
|
30 Days
Interval 29.0 to 34.0
|
29 Days
Confidence limits not estimable due to no variability around quartile
|
|
Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups
50% Quartile (95%CI)
|
57 Days
Interval 41.0 to 63.0
|
43 Days
Interval 30.0 to 58.0
|
|
Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups
75% Quartile (95%CI)
|
119 Days
Interval 69.0 to 123.0
|
112 Days
Interval 61.0 to 120.0
|
SECONDARY outcome
Timeframe: 18 months post-randomizationPopulation: Intent-to-treat
Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\[1\] of 0 and completing taper of glucocorticoid by 6 months post-randomization. \[1\] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease
Outcome measures
| Measure |
Rituximab
n=99 Participants
Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
|
Control Group
n=98 Participants
Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
|
|---|---|---|
|
Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups
25% Quartile (95%CI)
|
176 Days
Interval 173.0 to 177.0
|
177 Days
Interval 175.0 to 178.0
|
|
Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups
50% Quartile (95%CI)
|
180 Days
Interval 178.0 to 182.0
|
183 Days
Interval 180.0 to 187.0
|
|
Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups
75% Quartile (95%CI)
|
189 Days
Interval 183.0 to 253.0
|
266 Days
Interval 190.0 to 287.0
|
POST_HOC outcome
Timeframe: Randomization to censor at Crossover, Open-label or Best Medical Judgment (up to 18 months post-randomization)Population: Intent-to-treat
Number of subjects according to originally received treatment that experienced a serious adverse event through 18 months post-randomization or prior to being censored from analyses due to crossover, switching to open-label treatment, or best medical judgment for censor. Events are categorized by coded system organ classes (SOC). Within each SOC, a participant was counted once if the participant reported one or more events coded to that SOC.
Outcome measures
| Measure |
Rituximab
n=99 Participants
Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
|
Control Group
n=98 Participants
Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
|
|---|---|---|
|
Number of Subjects Experiencing Serious Adverse Events
Vascular Disorders
|
1 participants
|
7 participants
|
|
Number of Subjects Experiencing Serious Adverse Events
# Participants with at least one SAE
|
42 participants
|
37 participants
|
|
Number of Subjects Experiencing Serious Adverse Events
Blood and Lymphatic System Disorders
|
4 participants
|
5 participants
|
|
Number of Subjects Experiencing Serious Adverse Events
Cardiac Disorders
|
2 participants
|
2 participants
|
|
Number of Subjects Experiencing Serious Adverse Events
Eye Disorders
|
1 participants
|
1 participants
|
|
Number of Subjects Experiencing Serious Adverse Events
Gastrointestinal Disorders
|
4 participants
|
1 participants
|
|
Number of Subjects Experiencing Serious Adverse Events
General Disorders and Administration Site
|
5 participants
|
3 participants
|
|
Number of Subjects Experiencing Serious Adverse Events
Immune System Disorders
|
2 participants
|
2 participants
|
|
Number of Subjects Experiencing Serious Adverse Events
Infections and Infestations
|
12 participants
|
12 participants
|
|
Number of Subjects Experiencing Serious Adverse Events
Injury, Poisoning, and Procedural Complications
|
2 participants
|
0 participants
|
|
Number of Subjects Experiencing Serious Adverse Events
Investigations
|
2 participants
|
0 participants
|
|
Number of Subjects Experiencing Serious Adverse Events
Metabolism and Nutrition Disorders
|
2 participants
|
2 participants
|
|
Number of Subjects Experiencing Serious Adverse Events
Musculoskeletal and Connective Tissue Disorders
|
2 participants
|
3 participants
|
|
Number of Subjects Experiencing Serious Adverse Events
Neoplasms Benign, Malignant, and Unspecified
|
1 participants
|
2 participants
|
|
Number of Subjects Experiencing Serious Adverse Events
Nervous System Disorders
|
1 participants
|
0 participants
|
|
Number of Subjects Experiencing Serious Adverse Events
Pregnancy, Puerperium, and Perinatal Conditions
|
1 participants
|
0 participants
|
|
Number of Subjects Experiencing Serious Adverse Events
Psychiatric Disorders
|
1 participants
|
1 participants
|
|
Number of Subjects Experiencing Serious Adverse Events
Renal and Urinary Disorders
|
4 participants
|
3 participants
|
|
Number of Subjects Experiencing Serious Adverse Events
Respiratory, Thoracic, and Mediastinal Disorders
|
8 participants
|
8 participants
|
Adverse Events
Rituximab
Serious events: 60 serious events
Other events: 97 other events
Deaths: 0 deaths
Control Group
Serious events: 47 serious events
Other events: 97 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab
n=99 participants at risk
Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
|
Control Group
n=98 participants at risk
Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
|
|---|---|---|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Reproductive system and breast disorders
Endometriosis
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Influenza
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Osteomyelitis
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Pneumonia
|
8.1%
8/99 • Number of events 10 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
10.2%
10/98 • Number of events 11 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Post streptococcal glomerulonephritis
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Sepsis
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Septic shock
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Skin infection
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
2/99 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Investigations
Blood creatinine increased
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Investigations
C-reactive protein increased
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Investigations
Haemoglobin decreased
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
2.0%
2/98 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Metabolism and nutrition disorders
Gout
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
2.0%
2/98 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.0%
1/99 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
2.0%
2/98 • Number of events 6 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Nervous system disorders
Somnolence
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Nervous system disorders
Syncope
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Psychiatric disorders
Depression
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Psychiatric disorders
Suicide attempt
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Renal and urinary disorders
Bladder disorder
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Renal and urinary disorders
Renal failure
|
4.0%
4/99 • Number of events 4 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
2.0%
2/98 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Renal and urinary disorders
Renal failure acute
|
2.0%
2/99 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
3.1%
3/98 • Number of events 3 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Renal and urinary disorders
Renal failure chronic
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
2/99 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
2.0%
2/99 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
2.0%
2/98 • Number of events 3 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
2.0%
2/99 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
2.0%
2/98 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.0%
3/99 • Number of events 3 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
2.0%
2/98 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Wegener's granulomatosis
|
8.1%
8/99 • Number of events 9 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
4.1%
4/98 • Number of events 5 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Vascular disorders
Aortic dissection
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
8.2%
8/98 • Number of events 8 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Vascular disorders
Thrombosis
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
3/99 • Number of events 3 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
4.1%
4/98 • Number of events 6 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Blood and lymphatic system disorders
Autoimmune thrombocytopenia
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
2.0%
2/98 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.0%
3/99 • Number of events 5 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
2/99 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Cardiac disorders
Atrial tachycardia
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Eye disorders
Keratitis
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
2.0%
2/99 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
2/99 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Gastrointestinal disorders
Gastritis
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
2.0%
2/98 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
General disorders
Adverse drug reaction
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
General disorders
Asthenia
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
General disorders
Chest pain
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
General disorders
Chills
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
2.0%
2/98 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
General disorders
Multi-organ failure
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
General disorders
Pyrexia
|
2.0%
2/99 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
2.0%
2/98 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Immune system disorders
Hypersensitivity
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Abdominal abscess
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Abscess limb
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Bronchitis
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Cellulitis
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Cellulitis orbital
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Cellulitis staphylococcal
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Central line infection
|
0.00%
0/99 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Clostridial infection
|
1.0%
1/99 • Number of events 2 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Escherichia infection
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
0.00%
0/98 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Gastroenteritis viral
|
1.0%
1/99 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
1.0%
1/98 • Number of events 1 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
Other adverse events
| Measure |
Rituximab
n=99 participants at risk
Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
|
Control Group
n=98 participants at risk
Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
|
|---|---|---|
|
General disorders
Chest discomfort
|
6.1%
6/99 • Number of events 7 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
4.1%
4/98 • Number of events 4 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Nervous system disorders
Dysgeusia
|
6.1%
6/99 • Number of events 7 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
6.1%
6/98 • Number of events 6 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.1%
7/99 • Number of events 9 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
5.1%
5/98 • Number of events 5 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Blood and lymphatic system disorders
Anaemia
|
22.2%
22/99 • Number of events 28 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
18.4%
18/98 • Number of events 23 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.1%
13/99 • Number of events 30 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
39.8%
39/98 • Number of events 80 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
9/99 • Number of events 13 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
5.1%
5/98 • Number of events 6 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Ear and labyrinth disorders
Ear pain
|
7.1%
7/99 • Number of events 8 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
5.1%
5/98 • Number of events 5 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Endocrine disorders
Cushingoid
|
5.1%
5/99 • Number of events 6 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
6.1%
6/98 • Number of events 6 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Eye disorders
Vision blurred
|
4.0%
4/99 • Number of events 4 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
7.1%
7/98 • Number of events 7 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Gastrointestinal disorders
Diarrhoea
|
27.3%
27/99 • Number of events 35 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
20.4%
20/98 • Number of events 25 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
7/99 • Number of events 7 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
8.2%
8/98 • Number of events 8 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.1%
10/99 • Number of events 10 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
6.1%
6/98 • Number of events 6 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Gastrointestinal disorders
Nausea
|
25.3%
25/99 • Number of events 28 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
31.6%
31/98 • Number of events 41 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
8/99 • Number of events 12 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
13.3%
13/98 • Number of events 18 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
General disorders
Chest pain
|
6.1%
6/99 • Number of events 6 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
4.1%
4/98 • Number of events 4 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
General disorders
Chills
|
6.1%
6/99 • Number of events 7 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
5.1%
5/98 • Number of events 5 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
General disorders
Fatigue
|
26.3%
26/99 • Number of events 32 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
30.6%
30/98 • Number of events 42 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
General disorders
Oedema peripheral
|
22.2%
22/99 • Number of events 26 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
14.3%
14/98 • Number of events 19 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
General disorders
Pyrexia
|
10.1%
10/99 • Number of events 12 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
17.3%
17/98 • Number of events 25 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Bronchitis
|
7.1%
7/99 • Number of events 11 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
8.2%
8/98 • Number of events 11 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Herpes zoster
|
9.1%
9/99 • Number of events 10 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
8.2%
8/98 • Number of events 8 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Influenza
|
5.1%
5/99 • Number of events 6 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
5.1%
5/98 • Number of events 5 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
11/99 • Number of events 18 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
14.3%
14/98 • Number of events 22 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Sinusitis
|
16.2%
16/99 • Number of events 28 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
17.3%
17/98 • Number of events 29 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Upper respiratory tract infection
|
29.3%
29/99 • Number of events 43 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
24.5%
24/98 • Number of events 40 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Urinary tract infection
|
18.2%
18/99 • Number of events 24 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
7.1%
7/98 • Number of events 10 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.1%
7/99 • Number of events 8 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
4.1%
4/98 • Number of events 4 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Investigations
Alanine aminotransferase increased
|
15.2%
15/99 • Number of events 23 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
22.4%
22/98 • Number of events 30 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
11/99 • Number of events 14 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
16.3%
16/98 • Number of events 21 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Investigations
Blood creatinine increased
|
8.1%
8/99 • Number of events 10 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
10.2%
10/98 • Number of events 12 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Investigations
C-reactive protein increased
|
8.1%
8/99 • Number of events 10 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
9.2%
9/98 • Number of events 11 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Investigations
Haematocrit decreased
|
8.1%
8/99 • Number of events 8 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
16.3%
16/98 • Number of events 19 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Investigations
Haemoglobin decreased
|
6.1%
6/99 • Number of events 7 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
7.1%
7/98 • Number of events 8 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Investigations
Red blood cell sedimentation rate increased
|
5.1%
5/99 • Number of events 9 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
12.2%
12/98 • Number of events 14 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Investigations
Weight increased
|
6.1%
6/99 • Number of events 8 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
8.2%
8/98 • Number of events 8 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Investigations
White blood cell count decreased
|
6.1%
6/99 • Number of events 9 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
21.4%
21/98 • Number of events 43 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.1%
12/99 • Number of events 15 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
11.2%
11/98 • Number of events 11 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.1%
8/99 • Number of events 19 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
5.1%
5/98 • Number of events 6 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.0%
3/99 • Number of events 4 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
7.1%
7/98 • Number of events 9 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
34.3%
34/99 • Number of events 42 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
24.5%
24/98 • Number of events 34 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.1%
13/99 • Number of events 13 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
10.2%
10/98 • Number of events 10 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
8.1%
8/99 • Number of events 9 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
3.1%
3/98 • Number of events 3 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.2%
20/99 • Number of events 26 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
21.4%
21/98 • Number of events 23 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.1%
6/99 • Number of events 7 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
4.1%
4/98 • Number of events 5 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
11.1%
11/99 • Number of events 11 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
4.1%
4/98 • Number of events 4 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
5/99 • Number of events 6 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
8.2%
8/98 • Number of events 8 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.1%
13/99 • Number of events 17 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
10.2%
10/98 • Number of events 10 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Nervous system disorders
Dizziness
|
14.1%
14/99 • Number of events 17 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
12.2%
12/98 • Number of events 16 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Nervous system disorders
Headache
|
28.3%
28/99 • Number of events 31 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
25.5%
25/98 • Number of events 41 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Nervous system disorders
Hypoaesthesia
|
9.1%
9/99 • Number of events 10 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
8.2%
8/98 • Number of events 9 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Nervous system disorders
Paraesthesia
|
4.0%
4/99 • Number of events 7 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
7.1%
7/98 • Number of events 9 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Nervous system disorders
Tremor
|
10.1%
10/99 • Number of events 15 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
6.1%
6/98 • Number of events 6 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Psychiatric disorders
Depression
|
7.1%
7/99 • Number of events 7 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
6.1%
6/98 • Number of events 6 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Psychiatric disorders
Insomnia
|
18.2%
18/99 • Number of events 20 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
14.3%
14/98 • Number of events 15 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Renal and urinary disorders
Haematuria
|
6.1%
6/99 • Number of events 8 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
14.3%
14/98 • Number of events 16 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
32.3%
32/99 • Number of events 40 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
24.5%
24/98 • Number of events 31 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.1%
10/99 • Number of events 12 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
5.1%
5/98 • Number of events 7 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.2%
16/99 • Number of events 18 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
15.3%
15/98 • Number of events 19 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
18.2%
18/99 • Number of events 26 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
15.3%
15/98 • Number of events 23 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.1%
8/99 • Number of events 10 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
7.1%
7/98 • Number of events 8 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.1%
13/99 • Number of events 13 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
8.2%
8/98 • Number of events 9 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
11/99 • Number of events 14 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
3.1%
3/98 • Number of events 4 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
5.1%
5/99 • Number of events 7 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
6.1%
6/98 • Number of events 8 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.1%
7/99 • Number of events 8 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
7.1%
7/98 • Number of events 11 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.1%
6/99 • Number of events 6 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
5.1%
5/98 • Number of events 5 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
11/99 • Number of events 13 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
21.4%
21/98 • Number of events 21 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.1%
14/99 • Number of events 19 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
23.5%
23/98 • Number of events 28 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Vascular disorders
Flushing
|
6.1%
6/99 • Number of events 11 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
7.1%
7/98 • Number of events 8 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
|
Vascular disorders
Hypertension
|
14.1%
14/99 • Number of events 18 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
10.2%
10/98 • Number of events 10 • From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.
|
Additional Information
Associate Director, Clinical Research Program
DAIT/NIAID
Phone: (301) 594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place