Trial Outcomes & Findings for RAD001 and Bicalutamide for Androgen Independent Prostate Cancer (NCT NCT00630344)
NCT ID: NCT00630344
Last Updated: 2017-12-08
Results Overview
Overall response rate is the percentage of patients achieving response taking into consideration measurable disease, bone metastases, and PSA. PSA declines in the absence of both measurable disease and the appearance of new bone lesions or a response in measurable disease without an increase in PSA or the appearance of new bone lesions. Patients with stable disease (SD) lasting at least 6 months will also be considered responders. Per RECIST guidelines, for target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation is required within 4 weeks. Per modified PSAWG2 criteria (Scher H, Halabi S, Tannock I et al. JCO 2008) PSA response is defined as PSA decline ≥ 50% from baseline confirmed by a second measurement at least 4 weeks later.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
PSA was measured monthly and measurable disease on imaging assessed every 2 cycles in first 8 weeks and every 3 cycles thereafter. In this study cohort, patients were followed on treatment up to approximately 1 year.
Results posted on
2017-12-08
Participant Flow
Participant milestones
| Measure |
RAD001 + Bicalutamide
RAD001: once daily dose of 10 mg (5 mg tablets)
Bicalutamide: once daily dose of 50 mg (50 mg tablets)
1 cycle=28 days
Both agents are administered continuously until progression of disease or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
RAD001 + Bicalutamide
RAD001: once daily dose of 10 mg (5 mg tablets)
Bicalutamide: once daily dose of 50 mg (50 mg tablets)
1 cycle=28 days
Both agents are administered continuously until progression of disease or unacceptable toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Progressive Disease
|
19
|
|
Overall Study
Physician Decision
|
9
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Intercurrent Illness
|
1
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
RAD001 and Bicalutamide for Androgen Independent Prostate Cancer
Baseline characteristics by cohort
| Measure |
RAD-001 in Combination With Bicalutamide
n=36 Participants
RAD001: once daily dose of 10 mg (5 mg tablets)
Bicalutamide: once daily dose of 50 mg (50 mg tablets)
1 cycle=28 days
Both agents are administered continuously until progression of disease or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: PSA was measured monthly and measurable disease on imaging assessed every 2 cycles in first 8 weeks and every 3 cycles thereafter. In this study cohort, patients were followed on treatment up to approximately 1 year.Population: The analysis dataset is comprised of all treated patients.
Overall response rate is the percentage of patients achieving response taking into consideration measurable disease, bone metastases, and PSA. PSA declines in the absence of both measurable disease and the appearance of new bone lesions or a response in measurable disease without an increase in PSA or the appearance of new bone lesions. Patients with stable disease (SD) lasting at least 6 months will also be considered responders. Per RECIST guidelines, for target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation is required within 4 weeks. Per modified PSAWG2 criteria (Scher H, Halabi S, Tannock I et al. JCO 2008) PSA response is defined as PSA decline ≥ 50% from baseline confirmed by a second measurement at least 4 weeks later.
Outcome measures
| Measure |
RAD-001 + Bicalutamide
n=36 Participants
RAD001: once daily dose of 10 mg (5 mg tablets)
Bicalutamide: once daily dose of 50 mg (50 mg tablets)
1 cycle=28 days
Both agents are administered continuously until progression of disease or unacceptable toxicity.
|
|---|---|
|
Overall Response Rate
|
6 percentage of patients
Interval 1.0 to 16.0
|
SECONDARY outcome
Timeframe: Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.Population: The analysis dataset is comprised of all treated patients.
All grade 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 4 AE of any type during the time of observation.
Outcome measures
| Measure |
RAD-001 + Bicalutamide
n=36 Participants
RAD001: once daily dose of 10 mg (5 mg tablets)
Bicalutamide: once daily dose of 50 mg (50 mg tablets)
1 cycle=28 days
Both agents are administered continuously until progression of disease or unacceptable toxicity.
|
|---|---|
|
Incidence of Grade 4 Treatment-Related Toxicity
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.Population: The analysis dataset is comprised of all treated patients.
All grade 1-3 mucositis adverse events (AE) with treatment attribution of possible, probable or definite based on CTCAEv3 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 1-3 mucositis AE during the time of observation.
Outcome measures
| Measure |
RAD-001 + Bicalutamide
n=36 Participants
RAD001: once daily dose of 10 mg (5 mg tablets)
Bicalutamide: once daily dose of 50 mg (50 mg tablets)
1 cycle=28 days
Both agents are administered continuously until progression of disease or unacceptable toxicity.
|
|---|---|
|
Incidence of Grade 1-3 Treatment-Related Mucositis Toxicity
|
20 Participants
|
SECONDARY outcome
Timeframe: Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.Population: The analysis dataset is comprised of all treated patients.
All grade 1-3 rash adverse events (AE) with treatment attribution of possible, probable or definite based on CTCAEv3 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 1-3 rash AE during the time of observation.
Outcome measures
| Measure |
RAD-001 + Bicalutamide
n=36 Participants
RAD001: once daily dose of 10 mg (5 mg tablets)
Bicalutamide: once daily dose of 50 mg (50 mg tablets)
1 cycle=28 days
Both agents are administered continuously until progression of disease or unacceptable toxicity.
|
|---|---|
|
Incidence of Grade 1-3 Treatment-Related Rash Toxicity
|
17 Participants
|
SECONDARY outcome
Timeframe: Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.Population: The analysis dataset is comprised of all treated patients.
All grade 1-3 fatigue adverse events (AE) with treatment attribution of possible, probable or definite based on CTCAEv3 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 1-3 fatigue AE during the time of observation.
Outcome measures
| Measure |
RAD-001 + Bicalutamide
n=36 Participants
RAD001: once daily dose of 10 mg (5 mg tablets)
Bicalutamide: once daily dose of 50 mg (50 mg tablets)
1 cycle=28 days
Both agents are administered continuously until progression of disease or unacceptable toxicity.
|
|---|---|
|
Incidence of Grade 1-3 Treatment-Related Fatigue Toxicity
|
16 Participants
|
SECONDARY outcome
Timeframe: PSA was measured monthly and measurable disease on imaging assessed every 2 cycles in first 8 weeks and every 3 cycles thereafter. In this study cohort, patients were followed on treatment up to approximately 1 year.Population: The analysis dataset is comprised of all treated patients.
TTP estimated with Kaplan-Meier methods is defined as the time from treatment start to when PSA progression criteria is first met, or the date of measurable or non-measurable disease progression (PD). Absent progression, patients are censored at the date of the last PSA measurement. PSA progression is a ≥25% increase over baseline or nadir PSA, whichever is lowest with a minimum increase of 5 ng/mL. If PSA declines ≥50%, PSA progression is a ≥50% PSA increase above nadir with a minimum increase of 5 ng/mL or back to pretreatment baseline, whichever is lowest. PSA progression requires 2 week confirmation. Per RECIST, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. Non-measurable PD is defined as a worsening bone scan, as indicated by the appearance of two or more new lesions, the appearance of new non-bony metastases or a requirement for radiation therapy.
Outcome measures
| Measure |
RAD-001 + Bicalutamide
n=36 Participants
RAD001: once daily dose of 10 mg (5 mg tablets)
Bicalutamide: once daily dose of 50 mg (50 mg tablets)
1 cycle=28 days
Both agents are administered continuously until progression of disease or unacceptable toxicity.
|
|---|---|
|
Time to Progression (TTP)
|
8.7 weeks
Interval 0.0 to 43.6
|
Adverse Events
RAD-001+ Bicalutamide
Serious events: 19 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RAD-001+ Bicalutamide
n=36 participants at risk
RAD001: once daily dose of 10 mg (5 mg tablets)
Bicalutamide: once daily dose of 50 mg (50 mg tablets)
1 cycle=28 days
Both agents are administered continuously until progression of disease or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Eye disorders
Double vision
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam- oral cavity
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
General disorders
Fatigue
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
General disorders
Pain-other
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Infections and infestations
Infection neut-anal/perianl
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Investigations
Leukocytes
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Investigations
Alkaline phosphatase
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Investigations
CPK
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Investigations
Creatinine
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.3%
3/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Musculoskeletal and connective tissue disorders
Bone-pain
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Nervous system disorders
Neuropathy CN XII tongue
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Nervous system disorders
Speech impairment
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Nervous system disorders
Syncope
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Renal and urinary disorders
Glomerular filtration rate
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Renal and urinary disorders
Renal Failure
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
Other adverse events
| Measure |
RAD-001+ Bicalutamide
n=36 participants at risk
RAD001: once daily dose of 10 mg (5 mg tablets)
Bicalutamide: once daily dose of 50 mg (50 mg tablets)
1 cycle=28 days
Both agents are administered continuously until progression of disease or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Investigations
Neutrophils
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Blood and lymphatic system disorders
Hematologic-other
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Cardiac disorders
Cardiac-other
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
General disorders
Fatigue
|
38.9%
14/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
General disorders
Fever w/o neutropenia
|
8.3%
3/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Psychiatric disorders
Insomnia
|
8.3%
3/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
General disorders
Rigors/chills
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Investigations
Weight loss
|
11.1%
4/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
General disorders
Constitutional- other
|
8.3%
3/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Injury, poisoning and procedural complications
Burn
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Gastrointestinal disorders
Chelitis
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
4/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
8.3%
3/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
27.8%
10/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
16.7%
6/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Vascular disorders
Hot flashes
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Metabolism and nutrition disorders
Anorexia
|
19.4%
7/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Gastrointestinal disorders
Constipation
|
13.9%
5/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
25.0%
9/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Gastrointestinal disorders
Dysphagia
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam- oral cavity
|
27.8%
10/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
25.0%
9/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Gastrointestinal disorders
Nausea
|
19.4%
7/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Nervous system disorders
Taste disturbance
|
16.7%
6/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
3/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Gastrointestinal disorders
GI-other
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Renal and urinary disorders
Bladder- hemorrhage
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Renal and urinary disorders
Urinary hemorrhage NOS
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Nose- hemorrhage
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Vascular disorders
Hemorrhage-other
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Infections and infestations
Infection Gr0-2 neut- anal/perianl
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Infections and infestations
Infection Gr0-2 neut- lung
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
General disorders
Edema limb
|
8.3%
3/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Blood and lymphatic system disorders
Lymphatics-other
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Investigations
ALT- SGPT
|
8.3%
3/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Investigations
AST- SGOT
|
8.3%
3/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Investigations
Hypercholesterolemia
|
8.3%
3/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Investigations
CPK
|
16.7%
6/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Investigations
Creatinine
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Musculoskeletal and connective tissue disorders
Extremity upper (function)
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic lower extr muscle weak
|
8.3%
3/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Nervous system disorders
Nonneuropathic facial muscle weak
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Nervous system disorders
Dizziness
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Nervous system disorders
Extrapyramidal movement
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Nervous system disorders
Memory impairment
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Psychiatric disorders
Depression
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Nervous system disorders
Neuropathy CN VI lateral deviation eye
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Nervous system disorders
Neuropathy-sensory
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Psychiatric disorders
Psychosis
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Nervous system disorders
Tremor
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Eye disorders
Dry eye syndrome
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Eye disorders
Double vision
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Eye disorders
Vision-blurred
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Gastrointestinal disorders
Abdomen- pain
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Musculoskeletal and connective tissue disorders
Back- pain
|
19.4%
7/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Musculoskeletal and connective tissue disorders
Bone- pain
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Musculoskeletal and connective tissue disorders
Buttock- pain
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
General disorders
Chest/thoracic pain NOS
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Gastrointestinal disorders
Dental/teeth/peridontal- pain
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb- pain
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Nervous system disorders
Head/headache
|
11.1%
4/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Musculoskeletal and connective tissue disorders
Joint- pain
|
11.1%
4/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Musculoskeletal and connective tissue disorders
Muscle- pain
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Musculoskeletal and connective tissue disorders
Neck- pain
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Gastrointestinal disorders
Oral cavity- pain
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
General disorders
Pain NOS
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Reproductive system and breast disorders
Pelvic- pain
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Reproductive system and breast disorders
Penis- pain
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx- pain
|
8.3%
3/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
General disorders
Pain-other
|
13.9%
5/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.4%
7/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.9%
5/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
8.3%
3/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
5.6%
2/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Renal and urinary disorders
Cystitis
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Renal and urinary disorders
Obstruction-bladder
|
2.8%
1/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
11.1%
4/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
|
Reproductive system and breast disorders
Gynecomastia
|
8.3%
3/36 • Assessed each cycle during therapy and up to 30 days post-therapy completion which is approximately 1 year for patients in this study cohort.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place