Trial Outcomes & Findings for CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NCT NCT00109967)
NCT ID: NCT00109967
Last Updated: 2014-04-17
Results Overview
Complete Response (CR) - Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms. Partial Response (PR) requires a \>=50% decrease in sum of the products of the greatest dimension (SPD) of the six largest dominant nodes or nodal masses. Overall Response Rate (ORR) - The number of patients who achieve a CR or PR divided by the total number of evaluable patients. We report the Overall Response Rate here.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
Up to 12, 28-day cycles.
Results posted on
2014-04-17
Participant Flow
Seventy-one patients seen at 35 sites were enrolled on this trial between May 6, 2005 and March 6, 2009. Two patients canceled before receiving treatment and 69 patients were therefore included in the analysis. There were 48 patients in group 1 (rituximab-sensitive) and 21 (rituximab-refractory) in group 2.
The patients were stratified by their previous response to rituximab into rituximab sensitive (group 1) or rituximab refractory (group 2) groups. Rituximab refractory was defined as no response (stable disease or progression) or a response that lasted \<6 months the last time the patient received rituximab alone or rituximab with chemotherapy.
Participant milestones
| Measure |
Group I: Rituximab Sensitive
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m\^2 Given IV
temsirolimus: 25 mg given IV
|
Group II: Rituximab Refractory
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m\^2 Given IV
temsirolimus: 25 mg given IV
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
21
|
|
Overall Study
COMPLETED
|
30
|
15
|
|
Overall Study
NOT COMPLETED
|
20
|
6
|
Reasons for withdrawal
| Measure |
Group I: Rituximab Sensitive
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m\^2 Given IV
temsirolimus: 25 mg given IV
|
Group II: Rituximab Refractory
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m\^2 Given IV
temsirolimus: 25 mg given IV
|
|---|---|---|
|
Overall Study
Cancel Prior to Treatment
|
2
|
0
|
|
Overall Study
Adverse Event
|
12
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
|
Overall Study
Physician Decision
|
1
|
3
|
|
Overall Study
Death
|
0
|
2
|
Baseline Characteristics
CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Group I: Rituximab Sensitive
n=48 Participants
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m\^2 Given IV temsirolimus: 25 mg given IV
|
Group II: Rituximab Refractory
n=21 Participants
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m\^2 Given IV temsirolimus: 25 mg given IV
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 years
n=99 Participants
|
66 years
n=107 Participants
|
67 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=99 Participants
|
21 participants
n=107 Participants
|
69 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 12, 28-day cycles.Complete Response (CR) - Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms. Partial Response (PR) requires a \>=50% decrease in sum of the products of the greatest dimension (SPD) of the six largest dominant nodes or nodal masses. Overall Response Rate (ORR) - The number of patients who achieve a CR or PR divided by the total number of evaluable patients. We report the Overall Response Rate here.
Outcome measures
| Measure |
Group I: Rituximab Sensitive
n=48 Participants
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m\^2 Given IV
temsirolimus: 25 mg given IV
|
Group II: Rituximab Refractory
n=21 Participants
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m\^2 Given IV
temsirolimus: 25 mg given IV
|
|---|---|---|
|
Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria
|
62.5 percentage of patients
Interval 47.4 to 76.1
|
52.4 percentage of patients
Interval 29.8 to 74.3
|
SECONDARY outcome
Timeframe: Patients were followed up to five years after registration.Time to progression was defined as the time from registration to the date of progression. Patients who died without disease progression were censored at the date of their last evaluation. Patients who were still receiving treatment at the time of these analyses were censored at the date of their last evaluation. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Group I: Rituximab Sensitive
n=48 Participants
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m\^2 Given IV
temsirolimus: 25 mg given IV
|
Group II: Rituximab Refractory
n=21 Participants
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m\^2 Given IV
temsirolimus: 25 mg given IV
|
|---|---|---|
|
Time to Progression
|
10.9 months
Interval 8.0 to 12.8
|
5.4 months
Interval 1.8 to 9.4
|
SECONDARY outcome
Timeframe: Response duration is followed up to 5 years from registration.Population: Of the 48 Rituximab Sensitive patients, 30 patients had a response. Of the 21 Rituximab Refractory patients, 11 patients had a response. Therefore, this endpoint uses 30 patients from the Rituximab Sensitive group and 11 patients from the Rituximab Refractory group in the analysis.
Duration of response was defined as the time from the date of documented response to the date of progression. Patients who went off treatment due to other reasons (eg, adverse reactions, refusal of further treatment) were censored at that time. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Group I: Rituximab Sensitive
n=30 Participants
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m\^2 Given IV
temsirolimus: 25 mg given IV
|
Group II: Rituximab Refractory
n=11 Participants
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m\^2 Given IV
temsirolimus: 25 mg given IV
|
|---|---|---|
|
Duration of Response
|
11.0 months
Interval 7.1 to 13.2
|
6.6 months
Interval 2.0 to 20.9
|
SECONDARY outcome
Timeframe: Assessed during treatment (up to 12, 28-day cycles)As per the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3, toxicity was defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment by the treating physician. In this section, we report the number of participants that experienced at least one Grade 3 or higher adverse event.
Outcome measures
| Measure |
Group I: Rituximab Sensitive
n=48 Participants
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m\^2 Given IV
temsirolimus: 25 mg given IV
|
Group II: Rituximab Refractory
n=21 Participants
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m\^2 Given IV
temsirolimus: 25 mg given IV
|
|---|---|---|
|
Toxicity
Grade 3 or Higher
|
36 patients
|
17 patients
|
|
Toxicity
Grade 4 or Higher
|
7 patients
|
2 patients
|
SECONDARY outcome
Timeframe: Patients were followed for survival status for up to 5 years.Overall survival (OS) was defined as the time from registration to death resulting from any cause. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Group I: Rituximab Sensitive
n=48 Participants
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m\^2 Given IV
temsirolimus: 25 mg given IV
|
Group II: Rituximab Refractory
n=21 Participants
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.
rituximab: 375 mg/m\^2 Given IV
temsirolimus: 25 mg given IV
|
|---|---|---|
|
Overall Survival
|
32.6 months
Interval 24.9 to 39.7
|
24.2 months
Interval 5.7 to 30.0
|
Adverse Events
Group I: Rituximab Sensitive
Serious events: 16 serious events
Other events: 48 other events
Deaths: 0 deaths
Group II: Rituximab Refractory
Serious events: 7 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group I: Rituximab Sensitive
n=48 participants at risk
temsirolimus: 25 mg given IV
|
Group II: Rituximab Refractory
n=21 participants at risk
temsirolimus: 25 mg given IV
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Cardiac disorders
Myocardial ischemia
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Rectal pain
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Death NOS
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Disease progression
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Fever
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Localized edema
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Catheter related infection
|
4.2%
2/48 • Number of events 2
|
0.00%
0/21
|
|
Infections and infestations
Pneumonia
|
8.3%
4/48 • Number of events 4
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Skin infection
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Soft tissue infection
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
6.2%
3/48 • Number of events 5
|
4.8%
1/21 • Number of events 1
|
|
Investigations
Platelet count decreased
|
6.2%
3/48 • Number of events 5
|
9.5%
2/21 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Nervous system disorders
Tremor
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/48
|
9.5%
2/21 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.1%
1/48 • Number of events 3
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.3%
4/48 • Number of events 5
|
4.8%
1/21 • Number of events 1
|
|
Vascular disorders
Hematoma
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Vascular disorders
Hemorrhage
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Vascular disorders
Thrombosis
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
Other adverse events
| Measure |
Group I: Rituximab Sensitive
n=48 participants at risk
temsirolimus: 25 mg given IV
|
Group II: Rituximab Refractory
n=21 participants at risk
temsirolimus: 25 mg given IV
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
60.4%
29/48 • Number of events 143
|
76.2%
16/21 • Number of events 88
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/48
|
4.8%
1/21 • Number of events 2
|
|
Cardiac disorders
Left ventricular dysfunction
|
4.2%
2/48 • Number of events 2
|
0.00%
0/21
|
|
Cardiac disorders
Pericardial effusion
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Cardiac disorders
Sinus tachycardia
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Cardiac disorders
Ventricular tachycardia
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Ear and labyrinth disorders
External ear pain
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Endocrine disorders
Endocrine disorder
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Endocrine disorders
Hypothyroidism
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Eye disorders
Dry eye syndrome
|
2.1%
1/48 • Number of events 2
|
4.8%
1/21 • Number of events 9
|
|
Eye disorders
Eye disorder
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Eye disorders
Eye pain
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Eye disorders
Photophobia
|
2.1%
1/48 • Number of events 3
|
0.00%
0/21
|
|
Eye disorders
Watering eyes
|
2.1%
1/48 • Number of events 4
|
4.8%
1/21 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal distension
|
2.1%
1/48 • Number of events 2
|
0.00%
0/21
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Anal exam abnormal
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Constipation
|
12.5%
6/48 • Number of events 21
|
19.0%
4/21 • Number of events 9
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
16/48 • Number of events 51
|
28.6%
6/21 • Number of events 10
|
|
Gastrointestinal disorders
Dry mouth
|
4.2%
2/48 • Number of events 3
|
4.8%
1/21 • Number of events 5
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
3/48 • Number of events 6
|
0.00%
0/21
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
2.1%
1/48 • Number of events 3
|
14.3%
3/21 • Number of events 4
|
|
Gastrointestinal disorders
Esophageal mucositis
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Gastric mucositis
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Gastroscopy abnormal
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Gingival pain
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
39.6%
19/48 • Number of events 47
|
23.8%
5/21 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
22.9%
11/48 • Number of events 20
|
47.6%
10/21 • Number of events 25
|
|
Gastrointestinal disorders
Oral pain
|
2.1%
1/48 • Number of events 1
|
4.8%
1/21 • Number of events 2
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
3/48 • Number of events 4
|
4.8%
1/21 • Number of events 2
|
|
General disorders
Chest pain
|
4.2%
2/48 • Number of events 4
|
0.00%
0/21
|
|
General disorders
Chills
|
4.2%
2/48 • Number of events 3
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Disease progression
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Edema limbs
|
29.2%
14/48 • Number of events 50
|
23.8%
5/21 • Number of events 18
|
|
General disorders
Fatigue
|
75.0%
36/48 • Number of events 170
|
76.2%
16/21 • Number of events 74
|
|
General disorders
Fever
|
8.3%
4/48 • Number of events 5
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Localized edema
|
2.1%
1/48 • Number of events 8
|
0.00%
0/21
|
|
General disorders
Pain
|
6.2%
3/48 • Number of events 3
|
0.00%
0/21
|
|
Immune system disorders
Hypersensitivity
|
6.2%
3/48 • Number of events 4
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
2.1%
1/48 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Eye infection
|
2.1%
1/48 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Gingival infection
|
2.1%
1/48 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Infection
|
6.2%
3/48 • Number of events 3
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Nail infection
|
2.1%
1/48 • Number of events 3
|
0.00%
0/21
|
|
Infections and infestations
Pneumonia
|
6.2%
3/48 • Number of events 3
|
9.5%
2/21 • Number of events 3
|
|
Infections and infestations
Sinusitis
|
4.2%
2/48 • Number of events 4
|
9.5%
2/21 • Number of events 2
|
|
Infections and infestations
Skin infection
|
0.00%
0/48
|
9.5%
2/21 • Number of events 2
|
|
Infections and infestations
Small intestine infection
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
4.2%
2/48 • Number of events 2
|
9.5%
2/21 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Injury, poisoning and procedural complications
Bruising
|
2.1%
1/48 • Number of events 2
|
0.00%
0/21
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.1%
1/48 • Number of events 2
|
0.00%
0/21
|
|
Investigations
Alanine aminotransferase increased
|
4.2%
2/48 • Number of events 2
|
9.5%
2/21 • Number of events 4
|
|
Investigations
Alkaline phosphatase increased
|
14.6%
7/48 • Number of events 25
|
28.6%
6/21 • Number of events 7
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
4/48 • Number of events 8
|
19.0%
4/21 • Number of events 7
|
|
Investigations
Creatinine increased
|
12.5%
6/48 • Number of events 30
|
23.8%
5/21 • Number of events 16
|
|
Investigations
INR increased
|
10.4%
5/48 • Number of events 19
|
0.00%
0/21
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/48
|
4.8%
1/21 • Number of events 2
|
|
Investigations
Leukocyte count decreased
|
58.3%
28/48 • Number of events 174
|
76.2%
16/21 • Number of events 68
|
|
Investigations
Lipase increased
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
14.6%
7/48 • Number of events 64
|
14.3%
3/21 • Number of events 20
|
|
Investigations
Neutrophil count decreased
|
43.8%
21/48 • Number of events 97
|
61.9%
13/21 • Number of events 38
|
|
Investigations
Platelet count decreased
|
70.8%
34/48 • Number of events 176
|
71.4%
15/21 • Number of events 75
|
|
Investigations
Serum cholesterol increased
|
72.9%
35/48 • Number of events 136
|
71.4%
15/21 • Number of events 45
|
|
Investigations
Weight loss
|
27.1%
13/48 • Number of events 27
|
33.3%
7/21 • Number of events 26
|
|
Metabolism and nutrition disorders
Anorexia
|
27.1%
13/48 • Number of events 27
|
42.9%
9/21 • Number of events 22
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
43.8%
21/48 • Number of events 45
|
52.4%
11/21 • Number of events 38
|
|
Metabolism and nutrition disorders
Dehydration
|
2.1%
1/48 • Number of events 3
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
12.5%
6/48 • Number of events 12
|
9.5%
2/21 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
16.7%
8/48 • Number of events 28
|
9.5%
2/21 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.00%
0/48
|
9.5%
2/21 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
4.2%
2/48 • Number of events 7
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
2.1%
1/48 • Number of events 2
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
8.3%
4/48 • Number of events 6
|
19.0%
4/21 • Number of events 7
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
2.1%
1/48 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
10.4%
5/48 • Number of events 9
|
9.5%
2/21 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
2.1%
1/48 • Number of events 1
|
4.8%
1/21 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
77.1%
37/48 • Number of events 151
|
76.2%
16/21 • Number of events 63
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.6%
7/48 • Number of events 19
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.4%
5/48 • Number of events 14
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
4.2%
2/48 • Number of events 6
|
14.3%
3/21 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.1%
1/48 • Number of events 3
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
2.1%
1/48 • Number of events 2
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.4%
5/48 • Number of events 8
|
4.8%
1/21 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.2%
2/48 • Number of events 2
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
4/48 • Number of events 4
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
10.4%
5/48 • Number of events 15
|
9.5%
2/21 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
25.0%
12/48 • Number of events 30
|
9.5%
2/21 • Number of events 6
|
|
Nervous system disorders
Headache
|
12.5%
6/48 • Number of events 8
|
9.5%
2/21 • Number of events 2
|
|
Nervous system disorders
Peripheral motor neuropathy
|
8.3%
4/48 • Number of events 6
|
9.5%
2/21 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
12/48 • Number of events 41
|
23.8%
5/21 • Number of events 17
|
|
Nervous system disorders
Syncope
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Nervous system disorders
Tremor
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
6.2%
3/48 • Number of events 10
|
0.00%
0/21
|
|
Psychiatric disorders
Confusion
|
2.1%
1/48 • Number of events 6
|
4.8%
1/21 • Number of events 1
|
|
Psychiatric disorders
Depression
|
4.2%
2/48 • Number of events 7
|
0.00%
0/21
|
|
Psychiatric disorders
Insomnia
|
8.3%
4/48 • Number of events 7
|
9.5%
2/21 • Number of events 3
|
|
Renal and urinary disorders
Urinary frequency
|
4.2%
2/48 • Number of events 9
|
0.00%
0/21
|
|
Reproductive system and breast disorders
Reproductive tract disorder
|
2.1%
1/48 • Number of events 4
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.2%
3/48 • Number of events 7
|
14.3%
3/21 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
9/48 • Number of events 13
|
14.3%
3/21 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
8/48 • Number of events 14
|
23.8%
5/21 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
4/48 • Number of events 14
|
9.5%
2/21 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Laryngoscopy abnormal
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.1%
1/48 • Number of events 3
|
14.3%
3/21 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
18.8%
9/48 • Number of events 15
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/48
|
4.8%
1/21 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
8.3%
4/48 • Number of events 7
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
4.2%
2/48 • Number of events 4
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.2%
2/48 • Number of events 2
|
4.8%
1/21 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.1%
1/48 • Number of events 1
|
4.8%
1/21 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
20.8%
10/48 • Number of events 31
|
14.3%
3/21 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/48
|
4.8%
1/21 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
6/48 • Number of events 15
|
14.3%
3/21 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.2%
3/48 • Number of events 5
|
4.8%
1/21 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
54.2%
26/48 • Number of events 88
|
57.1%
12/21 • Number of events 40
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
2.1%
1/48 • Number of events 2
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.1%
1/48 • Number of events 7
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.1%
1/48 • Number of events 9
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Sweating
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.2%
2/48 • Number of events 4
|
0.00%
0/21
|
|
Vascular disorders
Flushing
|
0.00%
0/48
|
4.8%
1/21 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Vascular disorders
Hot flashes
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Vascular disorders
Hypertension
|
4.2%
2/48 • Number of events 6
|
0.00%
0/21
|
|
Vascular disorders
Hypotension
|
4.2%
2/48 • Number of events 2
|
0.00%
0/21
|
|
Vascular disorders
Phlebitis
|
2.1%
1/48 • Number of events 1
|
0.00%
0/21
|
|
Vascular disorders
Thrombosis
|
6.2%
3/48 • Number of events 3
|
4.8%
1/21 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60