Trial Outcomes & Findings for BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma (NCT NCT01034631)
NCT ID: NCT01034631
Last Updated: 2022-07-11
Results Overview
Phase I
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
154 participants
Primary outcome timeframe
Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months
Results posted on
2022-07-11
Participant Flow
Participant milestones
| Measure |
Phase I Participants
Participants in the phase I dose escalation portion of the study.
|
Phase II: Arm A
Phase II Participants, Arm A
Everolimus 10mg + BNC105P(Phase I MTD)
|
Phase II: Arm B Participants
Phase II: Arm B Participants
Everolimus 10mg followed by BNC105P monotherapy (16mg/m\^2) following progression or intolerable toxicity on Everolimus therapy.
|
|---|---|---|---|
|
Phase I
STARTED
|
15
|
0
|
0
|
|
Phase I
COMPLETED
|
12
|
0
|
0
|
|
Phase I
NOT COMPLETED
|
3
|
0
|
0
|
|
Phase II
STARTED
|
0
|
70
|
69
|
|
Phase II
COMPLETED
|
0
|
69
|
67
|
|
Phase II
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Phase I Participants
Participants in the phase I dose escalation portion of the study.
|
Phase II: Arm A
Phase II Participants, Arm A
Everolimus 10mg + BNC105P(Phase I MTD)
|
Phase II: Arm B Participants
Phase II: Arm B Participants
Everolimus 10mg followed by BNC105P monotherapy (16mg/m\^2) following progression or intolerable toxicity on Everolimus therapy.
|
|---|---|---|---|
|
Phase I
Symptomatic Deterioration before Treatme
|
3
|
0
|
0
|
|
Phase II
Not Evaluable per protocol
|
0
|
0
|
2
|
|
Phase II
Determined Ineligible per protocol
|
0
|
1
|
0
|
Baseline Characteristics
BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Phase I Participants
n=15 Participants
Participants in the phase I dose escalation portion of the study.
|
Phase II: Arm A
n=69 Participants
Phase II Participants, Arm A
Everolimus + BNC105P
|
Phase II: Arm B Participants
n=69 Participants
Phase II: Arm B Participants
Everolimus only, followed by BNC105P monotherapy
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 9 • n=5 Participants
|
62 years
STANDARD_DEVIATION 9 • n=7 Participants
|
63 years
STANDARD_DEVIATION 9 • n=5 Participants
|
62 years
STANDARD_DEVIATION 9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Initial Karnovksy Performance Score (KPS)
KPS 100
|
0 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Initial Karnovksy Performance Score (KPS)
KPS 90
|
9 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Initial Karnovksy Performance Score (KPS)
KPS 80
|
2 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Initial Karnovksy Performance Score (KPS)
KPS 70
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Memorial Sloan Kettering Cancer Center Risk Group (MSKCC
MSKCC Risk Group - Good
|
3 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Memorial Sloan Kettering Cancer Center Risk Group (MSKCC
MSKCC Risk Group - Intermediate
|
11 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Memorial Sloan Kettering Cancer Center Risk Group (MSKCC
MSKCC Risk Group - Poor
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Metastatic Site
Lung
|
13 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Metastatic Site
Liver
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Metastatic Site
Bone
|
8 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Metastatic Site
Brain
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Number of Prior Therapies
1 Prior Therapy
|
0 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Number of Prior Therapies
2 Prior Therapies
|
0 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Number of Prior Therapies
3 Prior Therapies
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Number of Prior Therapies
>=4 Prior Therapies
|
12 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Until disease progression or unacceptable toxicity, up to 24 cycles or 24 monthsPopulation: 12 participants completed at least one cycle of combination therapy and were evaluable.
Phase I
Outcome measures
| Measure |
Phase I Participants
n=12 Participants
15 total Participants were recruited to the phase I portion of the study.
|
Sequential Arm B:Everolimus Followed by BNC105P Monotherapy
Sequential Arm B: Everolimus 10 mg, 21 day cycle
Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P: BNC105P, up to 16 mg/m\^2
|
|---|---|---|
|
Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus.
|
16 mg/m^2
|
—
|
PRIMARY outcome
Timeframe: Until disease progression or unacceptable toxicity, up to 24 cycles or 24 monthsPopulation: 12 participants who completed at least one cycle of combination therapy.
Determine the toxicities of BNC105P in combination with everolimus. Drug-related treatment emergent adverse events by CTCAE grade 2 or greater are reported
Outcome measures
| Measure |
Phase I Participants
n=12 Participants
15 total Participants were recruited to the phase I portion of the study.
|
Sequential Arm B:Everolimus Followed by BNC105P Monotherapy
Sequential Arm B: Everolimus 10 mg, 21 day cycle
Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P: BNC105P, up to 16 mg/m\^2
|
|---|---|---|
|
Phase I: Toxicities of BNC105P in Combination With Everolimus.
AST-SGOT Grade 2
|
1 participants
|
—
|
|
Phase I: Toxicities of BNC105P in Combination With Everolimus.
Cough Grade 2
|
1 participants
|
—
|
|
Phase I: Toxicities of BNC105P in Combination With Everolimus.
Dyspepsia Grade 2
|
1 participants
|
—
|
|
Phase I: Toxicities of BNC105P in Combination With Everolimus.
Hemoglobin Grade 2
|
4 participants
|
—
|
|
Phase I: Toxicities of BNC105P in Combination With Everolimus.
Hemoglobin Grade 3
|
1 participants
|
—
|
|
Phase I: Toxicities of BNC105P in Combination With Everolimus.
Hypomagnesia Grade 2
|
1 participants
|
—
|
|
Phase I: Toxicities of BNC105P in Combination With Everolimus.
Low Platelets Grade 2
|
1 participants
|
—
|
|
Phase I: Toxicities of BNC105P in Combination With Everolimus.
Weight Loss Grade 2
|
1 participants
|
—
|
|
Phase I: Toxicities of BNC105P in Combination With Everolimus.
Fatigue Grade 2
|
2 participants
|
—
|
|
Phase I: Toxicities of BNC105P in Combination With Everolimus.
Left ventricular systolic dysfunction Grade 2
|
1 participants
|
—
|
|
Phase I: Toxicities of BNC105P in Combination With Everolimus.
Mucositis (oral) Grade 2
|
2 participants
|
—
|
|
Phase I: Toxicities of BNC105P in Combination With Everolimus.
Nail Infection Grade 2
|
1 participants
|
—
|
|
Phase I: Toxicities of BNC105P in Combination With Everolimus.
Diaphoresis Grade 2
|
1 participants
|
—
|
|
Phase I: Toxicities of BNC105P in Combination With Everolimus.
Pericardial effusion Grade 3
|
1 participants
|
—
|
|
Phase I: Toxicities of BNC105P in Combination With Everolimus.
Pleural effusion Grade 2
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: 6 monthsImprovement in 6-month PFS with the addition of BNC105P to everolimus. Progression is defined using RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Outcome measures
| Measure |
Phase I Participants
n=69 Participants
15 total Participants were recruited to the phase I portion of the study.
|
Sequential Arm B:Everolimus Followed by BNC105P Monotherapy
n=67 Participants
Sequential Arm B: Everolimus 10 mg, 21 day cycle
Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P: BNC105P, up to 16 mg/m\^2
|
|---|---|---|
|
Phase II: 6-month Progression Free Survival (PFS) With the Addition of BNC105P to Everolimus.
|
.3382 probability of 6MPFS
|
.3030 probability of 6MPFS
|
SECONDARY outcome
Timeframe: Until disease progression or unacceptable toxicity, up to 24 cycles or 24 monthsNumber of objective responses per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
Phase I Participants
n=15 Participants
15 total Participants were recruited to the phase I portion of the study.
|
Sequential Arm B:Everolimus Followed by BNC105P Monotherapy
Sequential Arm B: Everolimus 10 mg, 21 day cycle
Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P: BNC105P, up to 16 mg/m\^2
|
|---|---|---|
|
Phase I: Response Rate of BNC105P in Combination With Everolimus.
CR
|
0 Participants
|
—
|
|
Phase I: Response Rate of BNC105P in Combination With Everolimus.
PR
|
0 Participants
|
—
|
|
Phase I: Response Rate of BNC105P in Combination With Everolimus.
SD
|
8 Participants
|
—
|
|
Phase I: Response Rate of BNC105P in Combination With Everolimus.
PD
|
4 Participants
|
—
|
|
Phase I: Response Rate of BNC105P in Combination With Everolimus.
Unknown
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 14 participants has sufficient data collected for the analysis of this objective
Determine the PK Profile for BN105P in combination with everolimus by calculating the geometric mean half-life of BNC105P
Outcome measures
| Measure |
Phase I Participants
n=14 Participants
15 total Participants were recruited to the phase I portion of the study.
|
Sequential Arm B:Everolimus Followed by BNC105P Monotherapy
Sequential Arm B: Everolimus 10 mg, 21 day cycle
Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P: BNC105P, up to 16 mg/m\^2
|
|---|---|---|
|
Geometric Mean Half-life of BNC105 and BNC105P in Combination With Everolimus.
Half-life of BNC105
|
.32 hours
Interval 0.16 to 1.65
|
—
|
|
Geometric Mean Half-life of BNC105 and BNC105P in Combination With Everolimus.
Half-life of BNC105P
|
.08 hours
Interval 0.05 to 0.13
|
—
|
SECONDARY outcome
Timeframe: 12 monthsObjective response is defined as a confirmed CR or PR per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
Phase I Participants
n=69 Participants
15 total Participants were recruited to the phase I portion of the study.
|
Sequential Arm B:Everolimus Followed by BNC105P Monotherapy
n=67 Participants
Sequential Arm B: Everolimus 10 mg, 21 day cycle
Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P: BNC105P, up to 16 mg/m\^2
|
|---|---|---|
|
Phase II: Response Rate With Combination Therapy Compared to Everolimus Alone
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsMedian time to progression for arm P participants who crossed over to BNC105P monotherapy after progression. Progression is defined per RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Outcome measures
| Measure |
Phase I Participants
n=25 Participants
15 total Participants were recruited to the phase I portion of the study.
|
Sequential Arm B:Everolimus Followed by BNC105P Monotherapy
Sequential Arm B: Everolimus 10 mg, 21 day cycle
Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P: BNC105P, up to 16 mg/m\^2
|
|---|---|---|
|
Phase II: Progression Free Survival (PFS) With BNC105P Alone in Patients After Progressing on Everolimus.
|
1.8 months
Interval 1.74 to 2.04
|
—
|
SECONDARY outcome
Timeframe: 12 monthsDetermine adverse events of everolimus and BNC105P when administered as a combination or sequential regimen. Total number of serious and non-serious adverse events for Arm A and Arm B are summarized. Complete adverse event information is supplied in the Adverse Events reporting section.
Outcome measures
| Measure |
Phase I Participants
n=69 Participants
15 total Participants were recruited to the phase I portion of the study.
|
Sequential Arm B:Everolimus Followed by BNC105P Monotherapy
n=67 Participants
Sequential Arm B: Everolimus 10 mg, 21 day cycle
Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P: BNC105P, up to 16 mg/m\^2
|
|---|---|---|
|
Phase II: Adverse Events of Everolimus and BNC105P When Administered as a Combination or Sequential Regimen.
Non-Serious Adverse Events
|
1419 number of adverse events
|
1654 number of adverse events
|
|
Phase II: Adverse Events of Everolimus and BNC105P When Administered as a Combination or Sequential Regimen.
Serious Adverse Events
|
39 number of adverse events
|
50 number of adverse events
|
SECONDARY outcome
Timeframe: 60 monthsDetermine overall survival probability, up to a maximum of 5 years from registration for protocol therapy.
Outcome measures
| Measure |
Phase I Participants
n=69 Participants
15 total Participants were recruited to the phase I portion of the study.
|
Sequential Arm B:Everolimus Followed by BNC105P Monotherapy
n=67 Participants
Sequential Arm B: Everolimus 10 mg, 21 day cycle
Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P: BNC105P, up to 16 mg/m\^2
|
|---|---|---|
|
Phase II: Overall Survival
|
.15 probability of OS at 60 months.
|
.21 probability of OS at 60 months.
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Analysis was pre-specified to look at the correlation irrespective of arm.
Exploratory analysis of serum biomarkers were undertaken to generate a potential signature for response. The correlation with 6 month progression free survival P value for four plasma biomarkers is reported.
Outcome measures
| Measure |
Phase I Participants
n=44 Participants
15 total Participants were recruited to the phase I portion of the study.
|
Sequential Arm B:Everolimus Followed by BNC105P Monotherapy
Sequential Arm B: Everolimus 10 mg, 21 day cycle
Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
BNC105P: BNC105P, up to 16 mg/m\^2
|
|---|---|---|
|
Exploratory Objective: Correlation of PFS With Biomarkers
Serum Amyloid P-Component (SAP)
|
0.0184 Correlation with PFS P Value
|
—
|
|
Exploratory Objective: Correlation of PFS With Biomarkers
Sex Hormone-Binding Globulin (SHBG)
|
0.0063 Correlation with PFS P Value
|
—
|
|
Exploratory Objective: Correlation of PFS With Biomarkers
Matrix Metalloproteinase-9 (MMP-9)
|
0.0421 Correlation with PFS P Value
|
—
|
|
Exploratory Objective: Correlation of PFS With Biomarkers
Stem Cell Factor (SCF)
|
0.0291 Correlation with PFS P Value
|
—
|
Adverse Events
Phase I Participants
Serious events: 9 serious events
Other events: 15 other events
Deaths: 0 deaths
Phase II: Arm A
Serious events: 22 serious events
Other events: 70 other events
Deaths: 0 deaths
Phase II: Arm B Participants
Serious events: 31 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I Participants
n=15 participants at risk
Participants in the phase I dose escalation portion of the study.
|
Phase II: Arm A
n=70 participants at risk
Phase II Participants, Arm A
|
Phase II: Arm B Participants
n=69 participants at risk
Phase II: Arm B Participants
|
|---|---|---|---|
|
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Investigations
CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
2.9%
2/69 • Number of events 3 • 60 Months
|
|
Cardiac disorders
CARDIAC GENERAL
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
General disorders
DEATH NOT ASSOCIATED WITH CTCAE TERM / MULTI-ORGAN FAILURE
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Gastrointestinal disorders
DEHYDRATION
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
0.00%
0/15 • 60 Months
|
4.3%
3/70 • Number of events 4 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
FRACTURE
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Gastrointestinal disorders
GASTROINTESTINAL
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Renal and urinary disorders
HEMORRHAGE, GU / URINARY NOS
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / LUNG (PNEUMONIA)
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / RECTUM
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Infections and infestations
INFECTION
|
6.7%
1/15 • Number of events 1 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
|
13.3%
2/15 • Number of events 2 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
5.8%
4/69 • Number of events 4 • 60 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS)
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / LUNG (PNEUMONIA)
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
4.3%
3/69 • Number of events 3 • 60 Months
|
|
Cardiac disorders
LEFT VENTRICULAR SYSTOLIC DYSFUNCTION
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 2 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Blood and lymphatic system disorders
LYMPHATICS
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Psychiatric disorders
MENTAL STATUS
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-LOWER
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Gastrointestinal disorders
NAUSEA
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Gastrointestinal disorders
OBSTRUCTION, GI / SMALL BOWEL NOS
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
General disorders
PAIN / BACK
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
PAIN / BONE
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST/THORAX NOS
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
General disorders
PAIN / NECK
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
General disorders
PAIN / TUMOR PAIN
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Cardiac disorders
PERICARDIAL EFFUSION (NON-MALIGNANT)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Vascular disorders
PERIPHERAL ARTERIAL ISCHEMIA
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS/PULMONARY INFILTRATES
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Investigations
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 2 • 60 Months
|
4.3%
3/69 • Number of events 4 • 60 Months
|
|
Renal and urinary disorders
RENAL FAILURE
|
20.0%
3/15 • Number of events 3 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Renal and urinary disorders
RENAL/GENITOURINARY
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 2 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Vascular disorders
THROMBOSIS/EMBOLISM (VASCULAR ACCESS-RELATED)
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Nervous system disorders
TREMOR
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Vascular disorders
VASCULAR
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
Other adverse events
| Measure |
Phase I Participants
n=15 participants at risk
Participants in the phase I dose escalation portion of the study.
|
Phase II: Arm A
n=70 participants at risk
Phase II Participants, Arm A
|
Phase II: Arm B Participants
n=69 participants at risk
Phase II: Arm B Participants
|
|---|---|---|---|
|
Metabolism and nutrition disorders
ACIDOSIS (METABOLIC OR RESPIRATORY)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Investigations
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
13.3%
2/15 • Number of events 3 • 60 Months
|
10.0%
7/70 • Number of events 11 • 60 Months
|
10.1%
7/69 • Number of events 8 • 60 Months
|
|
Investigations
ALKALINE PHOSPHATASE
|
33.3%
5/15 • Number of events 6 • 60 Months
|
14.3%
10/70 • Number of events 14 • 60 Months
|
20.3%
14/69 • Number of events 19 • 60 Months
|
|
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
|
6.7%
1/15 • Number of events 3 • 60 Months
|
2.9%
2/70 • Number of events 5 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Immune system disorders
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
|
26.7%
4/15 • Number of events 4 • 60 Months
|
5.7%
4/70 • Number of events 4 • 60 Months
|
10.1%
7/69 • Number of events 7 • 60 Months
|
|
Immune system disorders
ALLERGY/IMMUNOLOGY
|
26.7%
4/15 • Number of events 5 • 60 Months
|
0.00%
0/70 • 60 Months
|
7.2%
5/69 • Number of events 6 • 60 Months
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
6.7%
1/15 • Number of events 2 • 60 Months
|
11.4%
8/70 • Number of events 14 • 60 Months
|
11.6%
8/69 • Number of events 13 • 60 Months
|
|
Gastrointestinal disorders
ANOREXIA
|
26.7%
4/15 • Number of events 7 • 60 Months
|
22.9%
16/70 • Number of events 18 • 60 Months
|
26.1%
18/69 • Number of events 21 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS (NON-SEPTIC)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
5.7%
4/70 • Number of events 14 • 60 Months
|
7.2%
5/69 • Number of events 5 • 60 Months
|
|
Gastrointestinal disorders
ASCITES (NON-MALIGNANT)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
13.3%
2/15 • Number of events 6 • 60 Months
|
12.9%
9/70 • Number of events 18 • 60 Months
|
13.0%
9/69 • Number of events 12 • 60 Months
|
|
Nervous system disorders
ATAXIA (INCOORDINATION)
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Ear and labyrinth disorders
AUDITORY/EAR
|
13.3%
2/15 • Number of events 2 • 60 Months
|
0.00%
0/70 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Immune system disorders
AUTOIMMUNE REACTION
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Investigations
BICARBONATE, SERUM-LOW
|
6.7%
1/15 • Number of events 2 • 60 Months
|
0.00%
0/70 • 60 Months
|
2.9%
2/69 • Number of events 3 • 60 Months
|
|
Investigations
BILIRUBIN (HYPERBILIRUBINEMIA)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 2 • 60 Months
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW
|
6.7%
1/15 • Number of events 1 • 60 Months
|
4.3%
3/70 • Number of events 4 • 60 Months
|
5.8%
4/69 • Number of events 4 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM, WHEEZING
|
0.00%
0/15 • 60 Months
|
4.3%
3/70 • Number of events 3 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Skin and subcutaneous tissue disorders
BRUISING (IN ABSENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA)
|
0.00%
0/15 • 60 Months
|
4.3%
3/70 • Number of events 4 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Investigations
CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
|
13.3%
2/15 • Number of events 6 • 60 Months
|
5.7%
4/70 • Number of events 4 • 60 Months
|
10.1%
7/69 • Number of events 18 • 60 Months
|
|
Investigations
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
11.4%
8/70 • Number of events 12 • 60 Months
|
8.7%
6/69 • Number of events 7 • 60 Months
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 2 • 60 Months
|
|
Cardiac disorders
CARDIAC GENERAL
|
6.7%
1/15 • Number of events 1 • 60 Months
|
4.3%
3/70 • Number of events 6 • 60 Months
|
5.8%
4/69 • Number of events 7 • 60 Months
|
|
Eye disorders
CATARACT
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 2 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
CERVICAL SPINE-RANGE OF MOTION
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Skin and subcutaneous tissue disorders
CHELITIS
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Investigations
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)
|
53.3%
8/15 • Number of events 9 • 60 Months
|
31.4%
22/70 • Number of events 39 • 60 Months
|
43.5%
30/69 • Number of events 40 • 60 Months
|
|
Blood and lymphatic system disorders
COAGULATION
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 3 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Nervous system disorders
CONFUSION
|
13.3%
2/15 • Number of events 2 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
4.3%
3/69 • Number of events 3 • 60 Months
|
|
Gastrointestinal disorders
CONSTIPATION
|
40.0%
6/15 • Number of events 9 • 60 Months
|
21.4%
15/70 • Number of events 17 • 60 Months
|
39.1%
27/69 • Number of events 33 • 60 Months
|
|
General disorders
CONSTITUTIONAL SYMPTOMS
|
13.3%
2/15 • Number of events 5 • 60 Months
|
4.3%
3/70 • Number of events 3 • 60 Months
|
8.7%
6/69 • Number of events 11 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
46.7%
7/15 • Number of events 10 • 60 Months
|
40.0%
28/70 • Number of events 35 • 60 Months
|
36.2%
25/69 • Number of events 36 • 60 Months
|
|
Investigations
CREATININE
|
33.3%
5/15 • Number of events 7 • 60 Months
|
21.4%
15/70 • Number of events 26 • 60 Months
|
18.8%
13/69 • Number of events 24 • 60 Months
|
|
Renal and urinary disorders
CYSTITIS
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Gastrointestinal disorders
DEHYDRATION
|
13.3%
2/15 • Number of events 2 • 60 Months
|
2.9%
2/70 • Number of events 3 • 60 Months
|
4.3%
3/69 • Number of events 3 • 60 Months
|
|
Gastrointestinal disorders
DENTAL: TEETH
|
6.7%
1/15 • Number of events 1 • 60 Months
|
2.9%
2/70 • Number of events 3 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN
|
6.7%
1/15 • Number of events 3 • 60 Months
|
18.6%
13/70 • Number of events 17 • 60 Months
|
23.2%
16/69 • Number of events 45 • 60 Months
|
|
Gastrointestinal disorders
DIARRHEA
|
46.7%
7/15 • Number of events 8 • 60 Months
|
34.3%
24/70 • Number of events 37 • 60 Months
|
24.6%
17/69 • Number of events 21 • 60 Months
|
|
Gastrointestinal disorders
DISTENSION/BLOATING, ABDOMINAL
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Nervous system disorders
DIZZINESS
|
6.7%
1/15 • Number of events 2 • 60 Months
|
4.3%
3/70 • Number of events 3 • 60 Months
|
8.7%
6/69 • Number of events 6 • 60 Months
|
|
Eye disorders
DRY EYE SYNDROME
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Gastrointestinal disorders
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
|
20.0%
3/15 • Number of events 3 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
10.1%
7/69 • Number of events 7 • 60 Months
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
26.7%
4/15 • Number of events 4 • 60 Months
|
7.1%
5/70 • Number of events 5 • 60 Months
|
10.1%
7/69 • Number of events 7 • 60 Months
|
|
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 3 • 60 Months
|
4.3%
3/69 • Number of events 3 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
20.0%
3/15 • Number of events 6 • 60 Months
|
37.1%
26/70 • Number of events 32 • 60 Months
|
39.1%
27/69 • Number of events 37 • 60 Months
|
|
Blood and lymphatic system disorders
EDEMA: HEAD AND NECK
|
6.7%
1/15 • Number of events 1 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
26.7%
4/15 • Number of events 4 • 60 Months
|
25.7%
18/70 • Number of events 33 • 60 Months
|
23.2%
16/69 • Number of events 22 • 60 Months
|
|
Blood and lymphatic system disorders
EDEMA: TRUNK/GENITAL
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Endocrine disorders
ENDOCRINE
|
6.7%
1/15 • Number of events 1 • 60 Months
|
2.9%
2/70 • Number of events 3 • 60 Months
|
4.3%
3/69 • Number of events 4 • 60 Months
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
5.8%
4/69 • Number of events 4 • 60 Months
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 3 • 60 Months
|
4.3%
3/69 • Number of events 3 • 60 Months
|
|
Nervous system disorders
EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
80.0%
12/15 • Number of events 27 • 60 Months
|
60.0%
42/70 • Number of events 60 • 60 Months
|
66.7%
46/69 • Number of events 83 • 60 Months
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
33.3%
5/15 • Number of events 11 • 60 Months
|
12.9%
9/70 • Number of events 11 • 60 Months
|
18.8%
13/69 • Number of events 17 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
FIBROSIS-DEEP CONNECTIVE TISSUE
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Gastrointestinal disorders
FLATULENCE
|
6.7%
1/15 • Number of events 1 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Skin and subcutaneous tissue disorders
FLUSHING
|
0.00%
0/15 • 60 Months
|
4.3%
3/70 • Number of events 3 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
FRACTURE
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Gastrointestinal disorders
GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
5.7%
4/70 • Number of events 5 • 60 Months
|
5.8%
4/69 • Number of events 5 • 60 Months
|
|
Gastrointestinal disorders
GASTROINTESTINAL
|
20.0%
3/15 • Number of events 7 • 60 Months
|
10.0%
7/70 • Number of events 11 • 60 Months
|
13.0%
9/69 • Number of events 12 • 60 Months
|
|
Investigations
GGT (GAMMA-GLUTAMYL TRANSPEPTIDASE)
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 8 • 60 Months
|
5.8%
4/69 • Number of events 9 • 60 Months
|
|
Eye disorders
GLAUCOMA
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
20.0%
3/15 • Number of events 3 • 60 Months
|
27.1%
19/70 • Number of events 51 • 60 Months
|
34.8%
24/69 • Number of events 62 • 60 Months
|
|
Investigations
GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)
|
0.00%
0/15 • 60 Months
|
4.3%
3/70 • Number of events 6 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Ear and labyrinth disorders
HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
26.7%
4/15 • Number of events 6 • 60 Months
|
7.1%
5/70 • Number of events 5 • 60 Months
|
21.7%
15/69 • Number of events 16 • 60 Months
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
73.3%
11/15 • Number of events 49 • 60 Months
|
50.0%
35/70 • Number of events 107 • 60 Months
|
55.1%
38/69 • Number of events 99 • 60 Months
|
|
Investigations
HEMOGLOBINURIA
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Blood and lymphatic system disorders
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
|
0.00%
0/15 • 60 Months
|
4.3%
3/70 • Number of events 6 • 60 Months
|
2.9%
2/69 • Number of events 6 • 60 Months
|
|
Gastrointestinal disorders
HEMORRHAGE, GI / RECTUM
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Renal and urinary disorders
HEMORRHAGE, GU / URINARY NOS
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
1.4%
1/69 • Number of events 2 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / BRONCHOPULMONARY NOS
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 3 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / LUNG
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
|
6.7%
1/15 • Number of events 1 • 60 Months
|
8.6%
6/70 • Number of events 7 • 60 Months
|
13.0%
9/69 • Number of events 13 • 60 Months
|
|
General disorders
HEMORRHAGE/BLEEDING
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
4.3%
3/69 • Number of events 3 • 60 Months
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
6.7%
1/15 • Number of events 1 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
HICCOUGHS (HICCUPS, SINGULTUS)
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Endocrine disorders
HOT FLASHES/FLUSHES
|
6.7%
1/15 • Number of events 1 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
1.4%
1/69 • Number of events 2 • 60 Months
|
|
Skin and subcutaneous tissue disorders
HYPERPIGMENTATION
|
13.3%
2/15 • Number of events 4 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Cardiac disorders
HYPERTENSION
|
60.0%
9/15 • Number of events 9 • 60 Months
|
32.9%
23/70 • Number of events 26 • 60 Months
|
36.2%
25/69 • Number of events 27 • 60 Months
|
|
Cardiac disorders
HYPOTENSION
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 3 • 60 Months
|
4.3%
3/69 • Number of events 3 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
13.3%
2/15 • Number of events 3 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Gastrointestinal disorders
ILEUS, GI (FUNCTIONAL OBSTRUCTION OF BOWEL, I.E., NEUROCONSTIPATION)
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Gastrointestinal disorders
INCONTINENCE, ANAL
|
6.7%
1/15 • Number of events 1 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Renal and urinary disorders
INCONTINENCE, URINARY
|
6.7%
1/15 • Number of events 1 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / BLADDER (URINARY)
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Infections and infestations
INFECTIONWITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / SINUS
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Skin and subcutaneous tissue disorders
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / SKIN (CELLULITES)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Infections and infestations
INFECTIONWITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / URINARY TRACT NOS
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Infections and infestations
INFECTION
|
13.3%
2/15 • Number of events 3 • 60 Months
|
7.1%
5/70 • Number of events 6 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / ABDOMEN NOS
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / BRONCHUS
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / EXTERNAL EAR (OTITIS EXTERNA)
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / EYE NOS
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LARYNX
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 4 • 60 Months
|
2.9%
2/69 • Number of events 3 • 60 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / ORAL CAVITY-GUMS (GINGIVITIS)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SINUS
|
6.7%
1/15 • Number of events 1 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS)
|
6.7%
1/15 • Number of events 3 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
4.3%
3/69 • Number of events 3 • 60 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / UNGUAL (NAILS)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / UPPER AIRWAY NOS
|
13.3%
2/15 • Number of events 2 • 60 Months
|
5.7%
4/70 • Number of events 4 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
|
6.7%
1/15 • Number of events 2 • 60 Months
|
4.3%
3/70 • Number of events 4 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / SINUS
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Skin and subcutaneous tissue disorders
INFECTION WITH UNKNOWN ANC / SKIN (CELLULITES)
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / UPPER AIRWAY NOS
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / URINARY TRACT NOS
|
13.3%
2/15 • Number of events 2 • 60 Months
|
0.00%
0/70 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / VAGINA
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Surgical and medical procedures
INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 3 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
General disorders
INSOMNIA
|
13.3%
2/15 • Number of events 2 • 60 Months
|
20.0%
14/70 • Number of events 18 • 60 Months
|
24.6%
17/69 • Number of events 18 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
JOINT-FUNCTION
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Cardiac disorders
LEFT VENTRICULAR SYSTOLIC DYSFUNCTION
|
6.7%
1/15 • Number of events 1 • 60 Months
|
4.3%
3/70 • Number of events 3 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
20.0%
3/15 • Number of events 4 • 60 Months
|
5.7%
4/70 • Number of events 16 • 60 Months
|
7.2%
5/69 • Number of events 15 • 60 Months
|
|
Investigations
LIPASE
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Hepatobiliary disorders
LIVER DYSFUNCTION/FAILURE (CLINICAL)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINE-RANGE OF MOTION
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Blood and lymphatic system disorders
LYMPHATICS
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
2.9%
2/69 • Number of events 4 • 60 Months
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
13.3%
2/15 • Number of events 7 • 60 Months
|
7.1%
5/70 • Number of events 13 • 60 Months
|
5.8%
4/69 • Number of events 8 • 60 Months
|
|
Investigations
MAGNESIUM, SERUM-HIGH (HYPERMAGNESEMIA)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Investigations
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
5.8%
4/69 • Number of events 4 • 60 Months
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
6.7%
1/15 • Number of events 1 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Investigations
METABOLIC/LABORATORY
|
20.0%
3/15 • Number of events 3 • 60 Months
|
12.9%
9/70 • Number of events 22 • 60 Months
|
15.9%
11/69 • Number of events 24 • 60 Months
|
|
Psychiatric disorders
MOOD ALTERATION / AGITATION
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
13.3%
2/15 • Number of events 3 • 60 Months
|
7.1%
5/70 • Number of events 5 • 60 Months
|
11.6%
8/69 • Number of events 9 • 60 Months
|
|
Psychiatric disorders
MOOD ALTERATION / DEPRESSION
|
6.7%
1/15 • Number of events 1 • 60 Months
|
8.6%
6/70 • Number of events 6 • 60 Months
|
13.0%
9/69 • Number of events 9 • 60 Months
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
|
20.0%
3/15 • Number of events 3 • 60 Months
|
18.6%
13/70 • Number of events 20 • 60 Months
|
30.4%
21/69 • Number of events 41 • 60 Months
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / PHARYNX
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / STOMACH
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
|
6.7%
1/15 • Number of events 1 • 60 Months
|
15.7%
11/70 • Number of events 11 • 60 Months
|
13.0%
9/69 • Number of events 28 • 60 Months
|
|
Eye disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTRAOCULAR
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-LOWER
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-UPPER
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED
|
13.3%
2/15 • Number of events 3 • 60 Months
|
4.3%
3/70 • Number of events 4 • 60 Months
|
4.3%
3/69 • Number of events 3 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE
|
46.7%
7/15 • Number of events 15 • 60 Months
|
11.4%
8/70 • Number of events 11 • 60 Months
|
18.8%
13/69 • Number of events 20 • 60 Months
|
|
Skin and subcutaneous tissue disorders
NAIL CHANGES
|
13.3%
2/15 • Number of events 3 • 60 Months
|
2.9%
2/70 • Number of events 3 • 60 Months
|
2.9%
2/69 • Number of events 3 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CAVITY/PARANASAL SINUS REACTIONS
|
13.3%
2/15 • Number of events 3 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
4.3%
3/69 • Number of events 3 • 60 Months
|
|
Gastrointestinal disorders
NAUSEA
|
60.0%
9/15 • Number of events 11 • 60 Months
|
25.7%
18/70 • Number of events 20 • 60 Months
|
30.4%
21/69 • Number of events 27 • 60 Months
|
|
Endocrine disorders
NEUROENDOCRINE: ADH SECRETION ABNORMALITY (E.G., SIADH OR LOW ADH)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Nervous system disorders
NEUROLOGY
|
6.7%
1/15 • Number of events 1 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
2.9%
2/69 • Number of events 5 • 60 Months
|
|
Nervous system disorders
NEUROPATHY: MOTOR
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
0.00%
0/15 • 60 Months
|
8.6%
6/70 • Number of events 6 • 60 Months
|
4.3%
3/69 • Number of events 4 • 60 Months
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
10.0%
7/70 • Number of events 15 • 60 Months
|
11.6%
8/69 • Number of events 16 • 60 Months
|
|
General disorders
OBESITY
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Eye disorders
OCULAR SURFACE DISEASE
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Eye disorders
OCULAR/VISUAL
|
26.7%
4/15 • Number of events 5 • 60 Months
|
4.3%
3/70 • Number of events 4 • 60 Months
|
2.9%
2/69 • Number of events 5 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
26.7%
4/15 • Number of events 4 • 60 Months
|
15.7%
11/70 • Number of events 12 • 60 Months
|
14.5%
10/69 • Number of events 15 • 60 Months
|
|
Gastrointestinal disorders
PAIN / ANUS
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
General disorders
PAIN / BACK
|
40.0%
6/15 • Number of events 11 • 60 Months
|
21.4%
15/70 • Number of events 18 • 60 Months
|
31.9%
22/69 • Number of events 35 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
PAIN / BONE
|
13.3%
2/15 • Number of events 7 • 60 Months
|
7.1%
5/70 • Number of events 7 • 60 Months
|
13.0%
9/69 • Number of events 15 • 60 Months
|
|
Reproductive system and breast disorders
PAIN / BREAST
|
6.7%
1/15 • Number of events 4 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
General disorders
PAIN / BUTTOCK
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
4.3%
3/69 • Number of events 3 • 60 Months
|
|
Cardiac disorders
PAIN / CARDIAC/HEART
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST WALL
|
46.7%
7/15 • Number of events 9 • 60 Months
|
8.6%
6/70 • Number of events 10 • 60 Months
|
15.9%
11/69 • Number of events 22 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST/THORAX NOS
|
13.3%
2/15 • Number of events 4 • 60 Months
|
8.6%
6/70 • Number of events 7 • 60 Months
|
10.1%
7/69 • Number of events 9 • 60 Months
|
|
Ear and labyrinth disorders
PAIN / EXTERNAL EAR
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 2 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
PAIN / EXTREMITY-LIMB
|
26.7%
4/15 • Number of events 7 • 60 Months
|
24.3%
17/70 • Number of events 26 • 60 Months
|
18.8%
13/69 • Number of events 18 • 60 Months
|
|
Eye disorders
PAIN / EYE
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
General disorders
PAIN / FACE
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 3 • 60 Months
|
1.4%
1/69 • Number of events 2 • 60 Months
|
|
General disorders
PAIN / HEAD/HEADACHE
|
20.0%
3/15 • Number of events 4 • 60 Months
|
10.0%
7/70 • Number of events 8 • 60 Months
|
24.6%
17/69 • Number of events 22 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
20.0%
3/15 • Number of events 4 • 60 Months
|
12.9%
9/70 • Number of events 9 • 60 Months
|
8.7%
6/69 • Number of events 7 • 60 Months
|
|
Renal and urinary disorders
PAIN / KIDNEY
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
General disorders
PAIN / LIP
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
PAIN / MUSCLE
|
13.3%
2/15 • Number of events 3 • 60 Months
|
4.3%
3/70 • Number of events 3 • 60 Months
|
4.3%
3/69 • Number of events 3 • 60 Months
|
|
General disorders
PAIN / NECK
|
0.00%
0/15 • 60 Months
|
4.3%
3/70 • Number of events 4 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Gastrointestinal disorders
PAIN / ORAL CAVITY
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Gastrointestinal disorders
PAIN / ORAL-GUMS
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
General disorders
PAIN / PAIN NOS
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 3 • 60 Months
|
|
General disorders
PAIN / PELVIS
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
General disorders
PAIN / PHANTOM (PAIN ASSOCIATED WITH MISSING LIMB)
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
General disorders
PAIN / SCALP
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Gastrointestinal disorders
PAIN / STOMACH
|
6.7%
1/15 • Number of events 1 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / THROAT/PHARYNX/LARYNX
|
6.7%
1/15 • Number of events 1 • 60 Months
|
2.9%
2/70 • Number of events 3 • 60 Months
|
5.8%
4/69 • Number of events 4 • 60 Months
|
|
General disorders
PAIN / TUMOR PAIN
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Renal and urinary disorders
PAIN / URETHRA
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
General disorders
PAIN
|
46.7%
7/15 • Number of events 12 • 60 Months
|
14.3%
10/70 • Number of events 18 • 60 Months
|
13.0%
9/69 • Number of events 16 • 60 Months
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Endocrine disorders
PANCREATIC ENDOCRINE: GLUCOSE INTOLERANCE
|
13.3%
2/15 • Number of events 2 • 60 Months
|
2.9%
2/70 • Number of events 3 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Cardiac disorders
PERICARDIAL EFFUSION (NON-MALIGNANT)
|
26.7%
4/15 • Number of events 6 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Psychiatric disorders
PERSONALITY/BEHAVIORAL
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Investigations
PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)
|
20.0%
3/15 • Number of events 4 • 60 Months
|
8.6%
6/70 • Number of events 6 • 60 Months
|
10.1%
7/69 • Number of events 10 • 60 Months
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Blood and lymphatic system disorders
PLATELETS
|
46.7%
7/15 • Number of events 12 • 60 Months
|
32.9%
23/70 • Number of events 36 • 60 Months
|
15.9%
11/69 • Number of events 16 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
|
33.3%
5/15 • Number of events 8 • 60 Months
|
4.3%
3/70 • Number of events 5 • 60 Months
|
4.3%
3/69 • Number of events 3 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS/PULMONARY INFILTRATES
|
13.3%
2/15 • Number of events 3 • 60 Months
|
4.3%
3/70 • Number of events 5 • 60 Months
|
4.3%
3/69 • Number of events 6 • 60 Months
|
|
Investigations
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
|
13.3%
2/15 • Number of events 3 • 60 Months
|
5.7%
4/70 • Number of events 4 • 60 Months
|
5.8%
4/69 • Number of events 10 • 60 Months
|
|
Investigations
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
13.3%
2/15 • Number of events 5 • 60 Months
|
12.9%
9/70 • Number of events 21 • 60 Months
|
7.2%
5/69 • Number of events 6 • 60 Months
|
|
Investigations
PROTEINURIA
|
26.7%
4/15 • Number of events 15 • 60 Months
|
15.7%
11/70 • Number of events 17 • 60 Months
|
17.4%
12/69 • Number of events 16 • 60 Months
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
20.0%
3/15 • Number of events 4 • 60 Months
|
15.7%
11/70 • Number of events 12 • 60 Months
|
7.2%
5/69 • Number of events 12 • 60 Months
|
|
Psychiatric disorders
PSYCHOSIS (HALLUCINATIONS/DELUSIONS)
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Surgical and medical procedures
PTT (PARTIAL THROMBOPLASTIN TIME)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
4.3%
3/70 • Number of events 3 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY
|
20.0%
3/15 • Number of events 4 • 60 Months
|
10.0%
7/70 • Number of events 8 • 60 Months
|
10.1%
7/69 • Number of events 24 • 60 Months
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
6.7%
1/15 • Number of events 2 • 60 Months
|
21.4%
15/70 • Number of events 19 • 60 Months
|
23.2%
16/69 • Number of events 21 • 60 Months
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
13.3%
2/15 • Number of events 2 • 60 Months
|
15.7%
11/70 • Number of events 14 • 60 Months
|
11.6%
8/69 • Number of events 10 • 60 Months
|
|
Skin and subcutaneous tissue disorders
RASH: DERMATITIS ASSOCIATED WITH RADIATION / RADIATION
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Skin and subcutaneous tissue disorders
RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Skin and subcutaneous tissue disorders
RASH: HAND-FOOT SKIN REACTION
|
0.00%
0/15 • 60 Months
|
7.1%
5/70 • Number of events 6 • 60 Months
|
5.8%
4/69 • Number of events 8 • 60 Months
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
2.9%
2/69 • Number of events 2 • 60 Months
|
|
Renal and urinary disorders
RENAL/GENITOURINARY
|
20.0%
3/15 • Number of events 3 • 60 Months
|
21.4%
15/70 • Number of events 21 • 60 Months
|
20.3%
14/69 • Number of events 17 • 60 Months
|
|
General disorders
RIGORS/CHILLS
|
20.0%
3/15 • Number of events 3 • 60 Months
|
4.3%
3/70 • Number of events 5 • 60 Months
|
8.7%
6/69 • Number of events 8 • 60 Months
|
|
Gastrointestinal disorders
SALIVARY GLAND CHANGES/SALIVA
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Nervous system disorders
SEIZURE
|
6.7%
1/15 • Number of events 1 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Skin and subcutaneous tissue disorders
SEROMA
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Investigations
SODIUM, SERUM-HIGH (HYPERNATREMIA)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
1.4%
1/70 • Number of events 2 • 60 Months
|
2.9%
2/69 • Number of events 3 • 60 Months
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
33.3%
5/15 • Number of events 10 • 60 Months
|
14.3%
10/70 • Number of events 15 • 60 Months
|
17.4%
12/69 • Number of events 16 • 60 Months
|
|
Reproductive system and breast disorders
STRICTURE/STENOSIS (INCLUDING ANASTOMOTIC), GU / PROSTATE
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / SINUS BRADYCARDIA
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / SINUS TACHYCARDIA
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
General disorders
SWEATING (DIAPHORESIS)
|
20.0%
3/15 • Number of events 5 • 60 Months
|
7.1%
5/70 • Number of events 6 • 60 Months
|
7.2%
5/69 • Number of events 5 • 60 Months
|
|
General disorders
SYNDROMES
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
20.0%
3/15 • Number of events 3 • 60 Months
|
7.1%
5/70 • Number of events 8 • 60 Months
|
15.9%
11/69 • Number of events 12 • 60 Months
|
|
Vascular disorders
THROMBOSIS/EMBOLISM (VASCULAR ACCESS-RELATED)
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
6.7%
1/15 • Number of events 1 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Endocrine disorders
THYROID FUNCTION, HIGH (HYPERTHYROIDISM, THYROTOXICOSIS)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
1.4%
1/70 • Number of events 1 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Endocrine disorders
THYROID FUNCTION, LOW (HYPOTHYROIDISM)
|
20.0%
3/15 • Number of events 3 • 60 Months
|
4.3%
3/70 • Number of events 3 • 60 Months
|
13.0%
9/69 • Number of events 9 • 60 Months
|
|
Investigations
TRIGLYCERIDE, SERUM-HIGH (HYPERTRIGLYCERIDEMIA)
|
40.0%
6/15 • Number of events 6 • 60 Months
|
30.0%
21/70 • Number of events 54 • 60 Months
|
40.6%
28/69 • Number of events 74 • 60 Months
|
|
Gastrointestinal disorders
ULCER, GI / DUODENUM
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Skin and subcutaneous tissue disorders
ULCERATION
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 2 • 60 Months
|
2.9%
2/69 • Number of events 3 • 60 Months
|
|
Investigations
URIC ACID, SERUM-HIGH (HYPERURICEMIA)
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Renal and urinary disorders
URINARY FREQUENCY/URGENCY
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
7.2%
5/69 • Number of events 5 • 60 Months
|
|
Renal and urinary disorders
URINE COLOR CHANGE
|
6.7%
1/15 • Number of events 1 • 60 Months
|
2.9%
2/70 • Number of events 3 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Skin and subcutaneous tissue disorders
URTICARIA (HIVES, WELTS, WHEALS)
|
6.7%
1/15 • Number of events 1 • 60 Months
|
0.00%
0/70 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Reproductive system and breast disorders
VAGINITIS (NOT DUE TO INFECTION)
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
0.00%
0/69 • 60 Months
|
|
Vascular disorders
VASCULAR
|
6.7%
1/15 • Number of events 2 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Vascular disorders
VESSEL INJURY-VEIN / SVC
|
0.00%
0/15 • 60 Months
|
0.00%
0/70 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Eye disorders
VISION-BLURRED VISION
|
13.3%
2/15 • Number of events 2 • 60 Months
|
4.3%
3/70 • Number of events 3 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
|
0.00%
0/15 • 60 Months
|
2.9%
2/70 • Number of events 2 • 60 Months
|
4.3%
3/69 • Number of events 3 • 60 Months
|
|
Gastrointestinal disorders
VOMITING
|
33.3%
5/15 • Number of events 5 • 60 Months
|
11.4%
8/70 • Number of events 8 • 60 Months
|
18.8%
13/69 • Number of events 16 • 60 Months
|
|
Eye disorders
WATERY EYE (EPIPHORA, TEARING)
|
0.00%
0/15 • 60 Months
|
1.4%
1/70 • Number of events 2 • 60 Months
|
1.4%
1/69 • Number of events 1 • 60 Months
|
|
General disorders
WEIGHT LOSS
|
46.7%
7/15 • Number of events 8 • 60 Months
|
7.1%
5/70 • Number of events 6 • 60 Months
|
18.8%
13/69 • Number of events 16 • 60 Months
|
Additional Information
Clinical Data Coordinator
Hoosier Cancer Research Network, Inc.
Phone: 317-921-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place