Trial Outcomes & Findings for Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment (NCT NCT00436618)
NCT ID: NCT00436618
Last Updated: 2019-10-22
Results Overview
CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, \>100000/μL platelets, \>11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions. Waldenstrom (subset of patients in the Uncommon Lymphomas group): \>50% reduction in serum immunoglobulin M(IgM) levels (by serum protein electrophoresis (SPEP)) during any point while in this study, and no appearance of new lesions. All others: at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
277 participants
Primary outcome timeframe
5 years
Results posted on
2019-10-22
Participant Flow
277 patients were accrued from 4 medical clinics in the United States between August 2005 and May 2010. One patient withdrew before starting treatment and thus excluded from the results.
Participant milestones
| Measure |
Relapsed Aggressive Non-Hodgkin Lymphoma
Study 1.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Relapsed Indolent Non-Hodgkin Lymphoma
Study 2.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Uncommon Lymphomas
Study 3. Includes Hodgkin's lymphomas.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
|---|---|---|---|
|
Overall Study
STARTED
|
114
|
55
|
107
|
|
Overall Study
COMPLETED
|
84
|
28
|
46
|
|
Overall Study
NOT COMPLETED
|
30
|
27
|
61
|
Reasons for withdrawal
| Measure |
Relapsed Aggressive Non-Hodgkin Lymphoma
Study 1.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Relapsed Indolent Non-Hodgkin Lymphoma
Study 2.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Uncommon Lymphomas
Study 3. Includes Hodgkin's lymphomas.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
8
|
11
|
|
Overall Study
Adverse Event
|
8
|
8
|
9
|
|
Overall Study
Alternate Treatment
|
3
|
4
|
12
|
|
Overall Study
Other Medical Problems
|
3
|
1
|
7
|
|
Overall Study
Death
|
4
|
2
|
3
|
|
Overall Study
New Primary or Other Reasons
|
6
|
2
|
12
|
|
Overall Study
Still on treatment
|
1
|
2
|
7
|
Baseline Characteristics
Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment
Baseline characteristics by cohort
| Measure |
Relapsed Aggressive Non-Hodgkin Lymphoma
n=114 Participants
Study 1.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Relapsed Indolent Non-Hodgkin Lymphoma
n=55 Participants
Study 2.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Uncommon Lymphomas
n=107 Participants
Study 3. Includes Hodgkin's lymphomas.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Total
n=276 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70 years
n=93 Participants
|
67 years
n=4 Participants
|
60 years
n=27 Participants
|
66 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
94 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
182 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=93 Participants
|
55 participants
n=4 Participants
|
107 participants
n=27 Participants
|
276 participants
n=483 Participants
|
|
Hodgkin versus Non-Hodgkin Lymphoma
Hodgkin Lymphoma
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
29 participants
n=27 Participants
|
29 participants
n=483 Participants
|
|
Hodgkin versus Non-Hodgkin Lymphoma
Non-Hodgkin Lymphoma
|
114 participants
n=93 Participants
|
55 participants
n=4 Participants
|
78 participants
n=27 Participants
|
247 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: 276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.
CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, \>100000/μL platelets, \>11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions. Waldenstrom (subset of patients in the Uncommon Lymphomas group): \>50% reduction in serum immunoglobulin M(IgM) levels (by serum protein electrophoresis (SPEP)) during any point while in this study, and no appearance of new lesions. All others: at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.
Outcome measures
| Measure |
Relapsed Aggressive Non-Hodgkin Lymphoma
n=114 Participants
Study 1.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Relapsed Indolent Non-Hodgkin Lymphoma
n=55 Participants
Study 2.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Uncommon Lymphomas
n=107 Participants
Study 3. Includes Hodgkin's lymphomas.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
|---|---|---|---|
|
Tumor Response, Defined by Disease: Chronic Lymphocytic Leukemia(CLL): Clinical Complete or Complete or Nodular Partial or Partial Remission, Waldenstrom: Complete or Partial Response, All Others: Complete or Complete Unconfirmed or Partial Response.
|
26 percentage of patients in group
Interval 19.0 to 35.0
|
35 percentage of patients in group
Interval 22.0 to 49.0
|
49 percentage of patients in group
Interval 39.0 to 58.0
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: 276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.
The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival was estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Relapsed Aggressive Non-Hodgkin Lymphoma
n=114 Participants
Study 1.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Relapsed Indolent Non-Hodgkin Lymphoma
n=55 Participants
Study 2.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Uncommon Lymphomas
n=107 Participants
Study 3. Includes Hodgkin's lymphomas.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
|---|---|---|---|
|
Overall Survival
|
0.66 years
Interval 0.44 to 0.99
|
2.45 years
Interval 1.04 to 4.97
|
3.41 years
Interval 2.31 to 5.13
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: 276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.
Progression-free survival is defined as the time from registration to the time of progression or death due to any cause. Progression-free survival was estimated using the method of Kaplan-Meier. Progression is defined as the following: CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): \>=50% increase in nodes from nadir or \>=50% increase in liver/spleen size from nadir. Waldenstrom (subset of patients in the Uncommon Lymphomas group): \>50% lymph node increase in SPD of \> 1 node or new nodes, or \>50% liver/spleen size increase, or \> 25% IgM (by SPEP) increase, or lymphocyte morphology transformation to a more aggressive histology. All Others: New lesions or \>=50% lymph nodes.
Outcome measures
| Measure |
Relapsed Aggressive Non-Hodgkin Lymphoma
n=114 Participants
Study 1.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Relapsed Indolent Non-Hodgkin Lymphoma
n=55 Participants
Study 2.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Uncommon Lymphomas
n=107 Participants
Study 3. Includes Hodgkin's lymphomas.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
|---|---|---|---|
|
Progression-free Survival
|
0.18 years
Interval 0.16 to 0.27
|
0.60 years
Interval 0.41 to 1.03
|
0.79 years
Interval 0.52 to 1.09
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: 276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.
The time to progression is defined as the time from registration to the time of progression. The distribution of time to progression was estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Relapsed Aggressive Non-Hodgkin Lymphoma
n=114 Participants
Study 1.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Relapsed Indolent Non-Hodgkin Lymphoma
n=55 Participants
Study 2.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Uncommon Lymphomas
n=107 Participants
Study 3. Includes Hodgkin's lymphomas.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
|---|---|---|---|
|
Time to Progression
|
0.18 years
Interval 0.16 to 0.29
|
0.60 years
Interval 0.42 to 1.16
|
0.90 years
Interval 0.62 to 1.49
|
Adverse Events
Relapsed Aggressive Non-Hodgkin Lymphoma
Serious events: 38 serious events
Other events: 113 other events
Deaths: 0 deaths
Relapsed Indolent Non-Hodgkin Lymphoma
Serious events: 11 serious events
Other events: 55 other events
Deaths: 0 deaths
Uncommon Lymphomas
Serious events: 25 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Relapsed Aggressive Non-Hodgkin Lymphoma
n=114 participants at risk
Study 1.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Relapsed Indolent Non-Hodgkin Lymphoma
n=55 participants at risk
Study 2.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Uncommon Lymphomas
n=107 participants at risk
Study 3. Includes Hodgkin's lymphomas.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
1.8%
2/114 • Number of events 2
|
0.00%
0/55
|
4.7%
5/107 • Number of events 6
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.00%
0/114
|
1.8%
1/55 • Number of events 1
|
0.00%
0/107
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Gastrointestinal disorders
Abdominal pain
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Gastrointestinal disorders
Colonic perforation
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
2/114 • Number of events 2
|
0.00%
0/55
|
1.9%
2/107 • Number of events 3
|
|
Gastrointestinal disorders
Gastritis
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Gastrointestinal disorders
Mucositis oral
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Gastrointestinal disorders
Nausea
|
2.6%
3/114 • Number of events 3
|
0.00%
0/55
|
0.00%
0/107
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
3/114 • Number of events 3
|
0.00%
0/55
|
0.00%
0/107
|
|
General disorders
Disease progression
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/114
|
0.00%
0/55
|
1.9%
2/107 • Number of events 2
|
|
General disorders
Fever
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Hepatobiliary disorders
Cholecystitis
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Immune system disorders
Hypersensitivity
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Infections and infestations
Biliary tract infection
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Infections and infestations
Gingival infection
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Infections and infestations
Opportunistic infection
|
0.00%
0/114
|
1.8%
1/55 • Number of events 1
|
0.00%
0/107
|
|
Infections and infestations
Pneumonia
|
4.4%
5/114 • Number of events 5
|
7.3%
4/55 • Number of events 5
|
3.7%
4/107 • Number of events 4
|
|
Infections and infestations
Sepsis
|
0.88%
1/114 • Number of events 1
|
3.6%
2/55 • Number of events 2
|
2.8%
3/107 • Number of events 3
|
|
Infections and infestations
Skin infection
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
1.9%
2/107 • Number of events 2
|
|
Infections and infestations
Upper respiratory infection
|
1.8%
2/114 • Number of events 2
|
0.00%
0/55
|
2.8%
3/107 • Number of events 5
|
|
Infections and infestations
Urinary tract infection
|
1.8%
2/114 • Number of events 2
|
0.00%
0/55
|
0.00%
0/107
|
|
Injury, poisoning and procedural complications
Fracture
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Investigations
Creatinine increased
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
2.6%
3/114 • Number of events 3
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
4.4%
5/114 • Number of events 5
|
5.5%
3/55 • Number of events 3
|
1.9%
2/107 • Number of events 2
|
|
Investigations
Platelet count decreased
|
13.2%
15/114 • Number of events 17
|
9.1%
5/55 • Number of events 7
|
11.2%
12/107 • Number of events 18
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
3/114 • Number of events 3
|
0.00%
0/55
|
0.00%
0/107
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
1.8%
2/114 • Number of events 2
|
0.00%
0/55
|
0.00%
0/107
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
2/114 • Number of events 2
|
0.00%
0/55
|
0.00%
0/107
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/114
|
1.8%
1/55 • Number of events 1
|
0.00%
0/107
|
|
Psychiatric disorders
Confusion
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Psychiatric disorders
Depression
|
0.00%
0/114
|
1.8%
1/55 • Number of events 1
|
0.93%
1/107 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Renal and urinary disorders
Urethral obstruction
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/114
|
1.8%
1/55 • Number of events 1
|
0.00%
0/107
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/114
|
1.8%
1/55 • Number of events 1
|
1.9%
2/107 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/114
|
1.8%
1/55 • Number of events 1
|
0.00%
0/107
|
|
Vascular disorders
Hypertension
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Vascular disorders
Hypotension
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Vascular disorders
Thrombosis
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
Other adverse events
| Measure |
Relapsed Aggressive Non-Hodgkin Lymphoma
n=114 participants at risk
Study 1.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Relapsed Indolent Non-Hodgkin Lymphoma
n=55 participants at risk
Study 2.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
Uncommon Lymphomas
n=107 participants at risk
Study 3. Includes Hodgkin's lymphomas.
Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/114
|
0.00%
0/55
|
1.9%
2/107 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/114
|
0.00%
0/55
|
1.9%
2/107 • Number of events 5
|
|
Investigations
Alkaline phosphatase increased
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
4.7%
5/107 • Number of events 12
|
|
Investigations
Aspartate aminotransferase increased
|
7.0%
8/114 • Number of events 12
|
5.5%
3/55 • Number of events 3
|
1.9%
2/107 • Number of events 7
|
|
Investigations
Cardiac troponin I increased
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Investigations
Creatinine increased
|
2.6%
3/114 • Number of events 3
|
0.00%
0/55
|
4.7%
5/107 • Number of events 5
|
|
Investigations
Leukocyte count decreased
|
61.4%
70/114 • Number of events 190
|
45.5%
25/55 • Number of events 78
|
62.6%
67/107 • Number of events 285
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/114
|
1.8%
1/55 • Number of events 2
|
0.00%
0/107
|
|
Investigations
Neutrophil count decreased
|
54.4%
62/114 • Number of events 106
|
45.5%
25/55 • Number of events 58
|
47.7%
51/107 • Number of events 148
|
|
Investigations
Platelet count decreased
|
79.8%
91/114 • Number of events 380
|
72.7%
40/55 • Number of events 177
|
69.2%
74/107 • Number of events 375
|
|
Investigations
Serum cholesterol increased
|
10.5%
12/114 • Number of events 21
|
10.9%
6/55 • Number of events 13
|
6.5%
7/107 • Number of events 16
|
|
Investigations
Weight loss
|
3.5%
4/114 • Number of events 4
|
1.8%
1/55 • Number of events 2
|
4.7%
5/107 • Number of events 14
|
|
Metabolism and nutrition disorders
Anorexia
|
7.9%
9/114 • Number of events 10
|
5.5%
3/55 • Number of events 3
|
3.7%
4/107 • Number of events 5
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
23.7%
27/114 • Number of events 45
|
14.5%
8/55 • Number of events 19
|
14.0%
15/107 • Number of events 31
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Metabolism and nutrition disorders
Dehydration
|
0.88%
1/114 • Number of events 1
|
3.6%
2/55 • Number of events 2
|
0.93%
1/107 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/114
|
0.00%
0/55
|
2.8%
3/107 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
93.9%
107/114 • Number of events 426
|
89.1%
49/55 • Number of events 207
|
96.3%
103/107 • Number of events 770
|
|
Cardiac disorders
Atrial fibrillation
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Cardiac disorders
Cardiac pain
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 3
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/114
|
0.00%
0/55
|
1.9%
2/107 • Number of events 2
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 2
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Eye disorders
Eye disorder
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal distension
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
2/114 • Number of events 2
|
3.6%
2/55 • Number of events 2
|
1.9%
2/107 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
1.8%
2/114 • Number of events 4
|
1.8%
1/55 • Number of events 5
|
1.9%
2/107 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
32.5%
37/114 • Number of events 57
|
40.0%
22/55 • Number of events 48
|
38.3%
41/107 • Number of events 93
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/114
|
0.00%
0/55
|
1.9%
2/107 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
2/114 • Number of events 2
|
0.00%
0/55
|
0.00%
0/107
|
|
Gastrointestinal disorders
Dysphagia
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.88%
1/114 • Number of events 1
|
1.8%
1/55 • Number of events 2
|
0.93%
1/107 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
11.4%
13/114 • Number of events 16
|
14.5%
8/55 • Number of events 11
|
19.6%
21/107 • Number of events 27
|
|
Gastrointestinal disorders
Nausea
|
28.9%
33/114 • Number of events 46
|
30.9%
17/55 • Number of events 22
|
32.7%
35/107 • Number of events 54
|
|
Gastrointestinal disorders
Oral pain
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/114
|
1.8%
1/55 • Number of events 1
|
0.00%
0/107
|
|
Gastrointestinal disorders
Proctoscopy abnormal
|
0.00%
0/114
|
1.8%
1/55 • Number of events 1
|
0.00%
0/107
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Gastrointestinal disorders
Rectal pain
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
1.9%
2/107 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
22.8%
26/114 • Number of events 31
|
12.7%
7/55 • Number of events 8
|
19.6%
21/107 • Number of events 29
|
|
General disorders
Chills
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
General disorders
Disease progression
|
0.88%
1/114 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
0.00%
0/107
|
|
General disorders
Edema limbs
|
3.5%
4/114 • Number of events 7
|
1.8%
1/55 • Number of events 8
|
3.7%
4/107 • Number of events 18
|
|
General disorders
Fatigue
|
29.8%
34/114 • Number of events 42
|
38.2%
21/55 • Number of events 22
|
29.9%
32/107 • Number of events 63
|
|
General disorders
Fever
|
7.0%
8/114 • Number of events 8
|
3.6%
2/55 • Number of events 2
|
0.93%
1/107 • Number of events 1
|
|
General disorders
General symptom
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
General disorders
Ill-defined disorder
|
0.88%
1/114 • Number of events 2
|
0.00%
0/55
|
0.00%
0/107
|
|
General disorders
Pain
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
General disorders
Visceral edema
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Infections and infestations
Anal infection
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
1.8%
2/114 • Number of events 2
|
0.00%
0/55
|
0.00%
0/107
|
|
Infections and infestations
Bronchitis
|
0.00%
0/114
|
3.6%
2/55 • Number of events 3
|
1.9%
2/107 • Number of events 2
|
|
Infections and infestations
Catheter related infection
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Infections and infestations
Cecal infection
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Infections and infestations
Gastric infection
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.93%
1/107 • Number of events 2
|
|
Infections and infestations
Gingival infection
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Infections and infestations
Infection
|
1.8%
2/114 • Number of events 2
|
1.8%
1/55 • Number of events 1
|
2.8%
3/107 • Number of events 3
|
|
Infections and infestations
Lip infection
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Infections and infestations
Otitis externa
|
0.00%
0/114
|
0.00%
0/55
|
1.9%
2/107 • Number of events 2
|
|
Infections and infestations
Penile infection
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Infections and infestations
Pleural infection
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Infections and infestations
Pneumonia
|
4.4%
5/114 • Number of events 6
|
10.9%
6/55 • Number of events 6
|
8.4%
9/107 • Number of events 11
|
|
Infections and infestations
Sepsis
|
0.00%
0/114
|
3.6%
2/55 • Number of events 2
|
1.9%
2/107 • Number of events 3
|
|
Infections and infestations
Sinusitis
|
1.8%
2/114 • Number of events 3
|
3.6%
2/55 • Number of events 2
|
3.7%
4/107 • Number of events 5
|
|
Infections and infestations
Skin infection
|
6.1%
7/114 • Number of events 8
|
3.6%
2/55 • Number of events 2
|
3.7%
4/107 • Number of events 5
|
|
Infections and infestations
Tooth infection
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Infections and infestations
Upper aerodigestive tract infection
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
1.8%
2/114 • Number of events 2
|
1.8%
1/55 • Number of events 1
|
6.5%
7/107 • Number of events 10
|
|
Infections and infestations
Urinary tract infection
|
2.6%
3/114 • Number of events 3
|
1.8%
1/55 • Number of events 2
|
1.9%
2/107 • Number of events 4
|
|
Infections and infestations
Viral hepatitis
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Infections and infestations
Wound infection
|
0.00%
0/114
|
1.8%
1/55 • Number of events 2
|
0.93%
1/107 • Number of events 2
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/114
|
0.00%
0/55
|
2.8%
3/107 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/114
|
1.8%
1/55 • Number of events 1
|
1.9%
2/107 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
1.8%
2/114 • Number of events 3
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.88%
1/114 • Number of events 1
|
5.5%
3/55 • Number of events 3
|
0.93%
1/107 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
12.3%
14/114 • Number of events 24
|
12.7%
7/55 • Number of events 13
|
8.4%
9/107 • Number of events 25
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.4%
5/114 • Number of events 6
|
5.5%
3/55 • Number of events 4
|
4.7%
5/107 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
2/114 • Number of events 2
|
0.00%
0/55
|
2.8%
3/107 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
3/114 • Number of events 3
|
5.5%
3/55 • Number of events 4
|
5.6%
6/107 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/114
|
1.8%
1/55 • Number of events 1
|
0.93%
1/107 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Nervous system disorders
Accessory nerve disorder
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Nervous system disorders
Ataxia
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Nervous system disorders
Dizziness
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
3.5%
4/114 • Number of events 6
|
1.8%
1/55 • Number of events 1
|
3.7%
4/107 • Number of events 6
|
|
Nervous system disorders
Headache
|
2.6%
3/114 • Number of events 3
|
0.00%
0/55
|
2.8%
3/107 • Number of events 3
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Nervous system disorders
Mini mental status examination abnormal
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Nervous system disorders
Neurological disorder NOS
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 2
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.6%
3/114 • Number of events 4
|
0.00%
0/55
|
0.00%
0/107
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.5%
4/114 • Number of events 25
|
0.00%
0/55
|
3.7%
4/107 • Number of events 4
|
|
Nervous system disorders
Radiculitis brachial
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Nervous system disorders
Speech disorder
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Nervous system disorders
Tremor
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.88%
1/114 • Number of events 3
|
0.00%
0/55
|
0.00%
0/107
|
|
Psychiatric disorders
Confusion
|
0.88%
1/114 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
0.00%
0/107
|
|
Psychiatric disorders
Depression
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/114
|
1.8%
1/55 • Number of events 1
|
0.00%
0/107
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/114
|
1.8%
1/55 • Number of events 1
|
0.93%
1/107 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/114
|
1.8%
1/55 • Number of events 1
|
0.00%
0/107
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/114
|
1.8%
1/55 • Number of events 1
|
0.00%
0/107
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.5%
4/114 • Number of events 4
|
7.3%
4/55 • Number of events 5
|
3.7%
4/107 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.9%
9/114 • Number of events 10
|
3.6%
2/55 • Number of events 4
|
8.4%
9/107 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.88%
1/114 • Number of events 1
|
3.6%
2/55 • Number of events 2
|
2.8%
3/107 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Laryngoscopy abnormal
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal stenosis
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/114
|
0.00%
0/55
|
2.8%
3/107 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/114
|
1.8%
1/55 • Number of events 1
|
0.00%
0/107
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.5%
4/114 • Number of events 6
|
7.3%
4/55 • Number of events 4
|
3.7%
4/107 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
0.00%
0/114
|
1.8%
1/55 • Number of events 1
|
0.00%
0/107
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
0.00%
0/107
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.88%
1/114 • Number of events 1
|
0.00%
0/55
|
1.9%
2/107 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/114
|
0.00%
0/55
|
3.7%
4/107 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.8%
2/114 • Number of events 2
|
1.8%
1/55 • Number of events 1
|
0.93%
1/107 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
7.0%
8/114 • Number of events 11
|
9.1%
5/55 • Number of events 6
|
12.1%
13/107 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/114
|
1.8%
1/55 • Number of events 2
|
0.93%
1/107 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 6
|
|
Vascular disorders
Hypertension
|
0.00%
0/114
|
1.8%
1/55 • Number of events 3
|
0.00%
0/107
|
|
Vascular disorders
Hypotension
|
0.00%
0/114
|
1.8%
1/55 • Number of events 1
|
1.9%
2/107 • Number of events 2
|
|
Vascular disorders
Thrombosis
|
1.8%
2/114 • Number of events 2
|
0.00%
0/55
|
0.00%
0/107
|
|
Vascular disorders
Vascular disorder
|
0.00%
0/114
|
0.00%
0/55
|
0.93%
1/107 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place