Trial Outcomes & Findings for Sirolimus and Pemetrexed to Treat Non-Small Cell Lung Cancer (NCT NCT00923273)
NCT ID: NCT00923273
Last Updated: 2019-11-26
Results Overview
The phase I component of the study are to determine the safety and tolerability of pemetrexed in human subjects with non small cell lung cancer (NSCLC), and to determine the maximum tolerated dose.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
42 participants
Primary outcome timeframe
5 weeks
Results posted on
2019-11-26
Participant Flow
DL5 wasn't tolerated. We expanded DL4, had 1 DLT of gr. 3 infection that was possibly related to study drugs or his cancer and declining health. The last subject on DL4 had gr. 4 neutropenia that lasted \<7days. We believe this wasn't significant and a lack of foresight to add length of neutropenia as DLT. IRB allowed DL4 with DLT stopping rule.
Participant milestones
| Measure |
Treatment Level 1: 3mg Load
Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m\^2
|
Treatment Level 2: 6mg Load
Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m\^2
|
Treatment Level 3: 6mg Load
Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m\^2
|
Treatment Level 4: 10mg Load
Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m\^2
|
Treatment Level 5: 15mg Load
Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m\^2
|
|---|---|---|---|---|---|
|
Phase I Treatment Period
STARTED
|
4
|
3
|
3
|
7
|
5
|
|
Phase I Treatment Period
COMPLETED
|
4
|
3
|
3
|
7
|
5
|
|
Phase I Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase II Treatment Period
STARTED
|
0
|
0
|
0
|
27
|
0
|
|
Phase II Treatment Period
COMPLETED
|
0
|
0
|
0
|
20
|
0
|
|
Phase II Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
7
|
0
|
Reasons for withdrawal
| Measure |
Treatment Level 1: 3mg Load
Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m\^2
|
Treatment Level 2: 6mg Load
Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m\^2
|
Treatment Level 3: 6mg Load
Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m\^2
|
Treatment Level 4: 10mg Load
Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m\^2
|
Treatment Level 5: 15mg Load
Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m\^2
|
|---|---|---|---|---|---|
|
Phase II Treatment Period
NE-brain mets/met disease prior enrollmt
|
0
|
0
|
0
|
1
|
0
|
|
Phase II Treatment Period
NE-not complete 2Cy trmt/no imaging done
|
0
|
0
|
0
|
6
|
0
|
Baseline Characteristics
Sirolimus and Pemetrexed to Treat Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Treatment Level 1: 3mg Load
n=4 Participants
Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m\^2
|
Treatment Level 2: 6mg Load
n=3 Participants
Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m\^2
|
Treatment Level 3: 6mg Load
n=3 Participants
Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m\^2
|
Treatment Level 4: 10 mg Load
n=27 Participants
Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m\^2
|
Treatment Level 5: 15mg Load
n=5 Participants
Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m\^2
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
|
Age, Continuous
|
64.65 years
STANDARD_DEVIATION 7.84 • n=5 Participants
|
71.57 years
STANDARD_DEVIATION 3.76 • n=7 Participants
|
61.7 years
STANDARD_DEVIATION 24.74 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 11.48 • n=4 Participants
|
56.08 years
STANDARD_DEVIATION 10.75 • n=21 Participants
|
60.6 years
STANDARD_DEVIATION 11.99 • n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
38 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
28 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 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
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
42 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 5 weeksThe phase I component of the study are to determine the safety and tolerability of pemetrexed in human subjects with non small cell lung cancer (NSCLC), and to determine the maximum tolerated dose.
Outcome measures
| Measure |
Treatment Level 1: 3mg Load
n=4 Participants
Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
Treatment Level 2: 6mg Load
n=3 Participants
Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
Treatment Level 3: 6mg Load
n=3 Participants
Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
Treatment Level 4: 10mg Load
n=7 Participants
Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
Treatment Level 5: 15mg Load
n=5 Participants
Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
|---|---|---|---|---|---|
|
Phase I: Maximum Tolerated Dose (MTD) of Pemetrexed
|
500 mg/m^2
|
500 mg/m^2
|
500 mg/m^2
|
500 mg/m^2
|
500 mg/m^2
|
PRIMARY outcome
Timeframe: 21 weeksPopulation: By formal criteria in the protocol, DL4 exceeds the MTD, and DL 3 would be expanded by 3 subjects to confirm it's tolerability. We believe that DL4 is safe, and that the observed DLTs at this DL are related to enrollment of a subject with a borderline performance status, and the omission of defining length of neutropenia as a DLT.
Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) is 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. Progressive disease (PD) is 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 |
Treatment Level 1: 3mg Load
n=27 Participants
Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
Treatment Level 2: 6mg Load
Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
Treatment Level 3: 6mg Load
Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
Treatment Level 4: 10mg Load
Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
Treatment Level 5: 15mg Load
Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
|---|---|---|---|---|---|
|
Phase II: Clinical Response Rate
Complete response
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Clinical Response Rate
Partial response
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Clinical Response Rate
Stable disease
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Clinical Response Rate
Progressive disease
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Phase II: Clinical Response Rate
Not evaluable
|
7 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 5 weeksThe phase I component of the study are to determine the safety and tolerability of sirolimus in human subjects with non small cell lung cancer (NSCLC), and to determine the maximum tolerated dose.
Outcome measures
| Measure |
Treatment Level 1: 3mg Load
n=4 Participants
Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
Treatment Level 2: 6mg Load
n=3 Participants
Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
Treatment Level 3: 6mg Load
n=3 Participants
Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
Treatment Level 4: 10mg Load
n=7 Participants
Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
Treatment Level 5: 15mg Load
n=5 Participants
Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
|---|---|---|---|---|---|
|
Phase I: Maximum Tolerated Dose (MTD) of Sirolimus
|
10 mg/m^2
|
10 mg/m^2
|
10 mg/m^2
|
10 mg/m^2
|
10 mg/m^2
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 45 monthsHere is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Treatment Level 1: 3mg Load
n=4 Participants
Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
Treatment Level 2: 6mg Load
n=3 Participants
Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
Treatment Level 3: 6mg Load
n=3 Participants
Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
Treatment Level 4: 10mg Load
n=27 Participants
Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
Treatment Level 5: 15mg Load
n=5 Participants
Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m\^2 All subjects completed the intervention and phase I outcome measure.
|
|---|---|---|---|---|---|
|
Number of Participants With Serious and Non-Serious Adverse Events
Subjects from phase I
|
4 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Serious and Non-Serious Adverse Events
8subjects prior peme & 12 subjects peme naive
|
0 Participants
|
0 Participants
|
0 Participants
|
20 Participants
|
0 Participants
|
Adverse Events
Treatment Level 1: 3mg Load
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment Level 2: 6mg Load
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment Level 3: 6mg Load
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Treatment Level 4: 10 mg Load
Serious events: 7 serious events
Other events: 27 other events
Deaths: 0 deaths
Treatment Level 5: 15mg Load
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Level 1: 3mg Load
n=4 participants at risk
Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m\^2
|
Treatment Level 2: 6mg Load
n=3 participants at risk
Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m\^2
|
Treatment Level 3: 6mg Load
n=3 participants at risk
Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m\^2
|
Treatment Level 4: 10 mg Load
n=27 participants at risk
Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m\^2
|
Treatment Level 5: 15mg Load
n=5 participants at risk
Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m\^2
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Edema: limb
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
General disorders
Death not associated with CTCAE term: Disease progression NOS
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Infections and infestations
Febrile neutropenia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Infections and infestations
Infection
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: lung (pneumonia)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper respiratory - Other (specify, pulmonary infiltrate, right lung)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Blood and lymphatic system disorders
CD4 count
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
Other adverse events
| Measure |
Treatment Level 1: 3mg Load
n=4 participants at risk
Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m\^2
|
Treatment Level 2: 6mg Load
n=3 participants at risk
Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m\^2
|
Treatment Level 3: 6mg Load
n=3 participants at risk
Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m\^2
|
Treatment Level 4: 10 mg Load
n=27 participants at risk
Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m\^2
|
Treatment Level 5: 15mg Load
n=5 participants at risk
Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m\^2
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
25.0%
1/4 • Number of events 7 • Date treatment consent signed to date off study, approximately 45 months.
|
66.7%
2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
22.2%
6/27 • Number of events 20 • Date treatment consent signed to date off study, approximately 45 months.
|
60.0%
3/5 • Number of events 13 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
AST/SGOT (serum glutamic oxaloacetic transaminase)
|
75.0%
3/4 • Number of events 9 • Date treatment consent signed to date off study, approximately 45 months.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
18.5%
5/27 • Number of events 11 • Date treatment consent signed to date off study, approximately 45 months.
|
60.0%
3/5 • Number of events 10 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
50.0%
2/4 • Number of events 11 • Date treatment consent signed to date off study, approximately 45 months.
|
100.0%
3/3 • Number of events 14 • Date treatment consent signed to date off study, approximately 45 months.
|
100.0%
3/3 • Number of events 8 • Date treatment consent signed to date off study, approximately 45 months.
|
25.9%
7/27 • Number of events 16 • Date treatment consent signed to date off study, approximately 45 months.
|
100.0%
5/5 • Number of events 13 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
100.0%
4/4 • Number of events 7 • Date treatment consent signed to date off study, approximately 45 months.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
11.1%
3/27 • Number of events 6 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Anorexia
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
59.3%
16/27 • Number of events 19 • Date treatment consent signed to date off study, approximately 45 months.
|
80.0%
4/5 • Number of events 7 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
50.0%
2/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
11.1%
3/27 • Number of events 16 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
14.8%
4/27 • Number of events 10 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Nervous system disorders
Cognitive disturbance
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Nervous system disorders
Confusion
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
22.2%
6/27 • Number of events 6 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Creatinine
|
25.0%
1/4 • Number of events 8 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
11.1%
3/27 • Number of events 5 • Date treatment consent signed to date off study, approximately 45 months.
|
60.0%
3/5 • Number of events 12 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
48.1%
13/27 • Number of events 15 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Eye disorders
Dry eye syndrome
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
25.9%
7/27 • Number of events 10 • Date treatment consent signed to date off study, approximately 45 months.
|
60.0%
3/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Blood and lymphatic system disorders
Edema: limb
|
25.0%
1/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
14.8%
4/27 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Blood and lymphatic system disorders
Edema: trunk/genital
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
FEV(1)
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
50.0%
2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
66.7%
18/27 • Number of events 27 • Date treatment consent signed to date off study, approximately 45 months.
|
100.0%
5/5 • Number of events 13 • Date treatment consent signed to date off study, approximately 45 months.
|
|
General disorders
Fever
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
29.6%
8/27 • Number of events 9 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Flatulence
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
GGT (gamma-Glutamyl transpeptidase)
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, bloating)
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Glomerular filtration rate
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
25.0%
1/4 • Number of events 16 • Date treatment consent signed to date off study, approximately 45 months.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
9/27 • Number of events 32 • Date treatment consent signed to date off study, approximately 45 months.
|
80.0%
4/5 • Number of events 14 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Hemoglobin
|
75.0%
3/4 • Number of events 23 • Date treatment consent signed to date off study, approximately 45 months.
|
100.0%
3/3 • Number of events 17 • Date treatment consent signed to date off study, approximately 45 months.
|
100.0%
3/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 45 months.
|
44.4%
12/27 • Number of events 26 • Date treatment consent signed to date off study, approximately 45 months.
|
100.0%
5/5 • Number of events 34 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage/Bleeding - Other (Specify, nose)
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Infections and infestations
Infection - Other (Specify, pneumonia)
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
General disorders
Insomnia
|
75.0%
3/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
11.1%
3/27 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
25.0%
1/4 • Number of events 7 • Date treatment consent signed to date off study, approximately 45 months.
|
66.7%
2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
100.0%
3/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
9/27 • Number of events 23 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 8 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
75.0%
3/4 • Number of events 14 • Date treatment consent signed to date off study, approximately 45 months.
|
66.7%
2/3 • Number of events 15 • Date treatment consent signed to date off study, approximately 45 months.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
63.0%
17/27 • Number of events 49 • Date treatment consent signed to date off study, approximately 45 months.
|
100.0%
5/5 • Number of events 29 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
50.0%
2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
18.5%
5/27 • Number of events 10 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
50.0%
2/4 • Number of events 8 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
40.7%
11/27 • Number of events 22 • Date treatment consent signed to date off study, approximately 45 months.
|
80.0%
4/5 • Number of events 10 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Nervous system disorders
Mood alteration: anxiety
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Nervous system disorders
Mood alteration: depression
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam): oral cavity
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
22.2%
6/27 • Number of events 9 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
51.9%
14/27 • Number of events 16 • Date treatment consent signed to date off study, approximately 45 months.
|
80.0%
4/5 • Number of events 5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Nervous system disorders
Neuropathy: sensory
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
14.8%
4/27 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
25.0%
1/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
66.7%
2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
37.0%
10/27 • Number of events 20 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 7 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Blood and lymphatic system disorders
PTT (Partial thromboplastin time)
|
50.0%
2/4 • Number of events 6 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
100.0%
3/3 • Number of events 11 • Date treatment consent signed to date off study, approximately 45 months.
|
11.1%
3/27 • Number of events 7 • Date treatment consent signed to date off study, approximately 45 months.
|
80.0%
4/5 • Number of events 7 • Date treatment consent signed to date off study, approximately 45 months.
|
|
General disorders
Pain - Other (Specify, L rib; R costal margin; shoulder)
|
50.0%
2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Pain: Abdomen NOS
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
22.2%
6/27 • Number of events 8 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Musculoskeletal and connective tissue disorders
Pain: Bone
|
25.0%
1/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Musculoskeletal and connective tissue disorders
Pain: extremity-limb
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Pain: oral cavity
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
50.0%
2/4 • Number of events 14 • Date treatment consent signed to date off study, approximately 45 months.
|
66.7%
2/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
48.1%
13/27 • Number of events 36 • Date treatment consent signed to date off study, approximately 45 months.
|
60.0%
3/5 • Number of events 7 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Blood and lymphatic system disorders
Platelets
|
25.0%
1/4 • Number of events 7 • Date treatment consent signed to date off study, approximately 45 months.
|
66.7%
2/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 45 months.
|
100.0%
3/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
9/27 • Number of events 17 • Date treatment consent signed to date off study, approximately 45 months.
|
80.0%
4/5 • Number of events 9 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
14.8%
4/27 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
25.0%
1/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Proteinuria
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Skin and subcutaneous tissue disorders
Pruritis/itching
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
18.5%
5/27 • Number of events 5 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Skin and subcutaneous tissue disorders
Rash/acneiform
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
40.7%
11/27 • Number of events 12 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, renal insufficiency)
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
General disorders
Rigors/chills
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
25.0%
1/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
100.0%
4/4 • Number of events 6 • Date treatment consent signed to date off study, approximately 45 months.
|
66.7%
2/3 • Number of events 13 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
40.7%
11/27 • Number of events 32 • Date treatment consent signed to date off study, approximately 45 months.
|
80.0%
4/5 • Number of events 11 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Nervous system disorders
Speech impairment (e.g., dysphagia or aphasia)
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: sinus tachycardia
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
14.8%
4/27 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
General disorders
Sweating (diaphoresis)
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Nervous system disorders
Tremor
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
25.0%
1/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Vital capacity
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
9/27 • Number of events 13 • Date treatment consent signed to date off study, approximately 45 months.
|
60.0%
3/5 • Number of events 6 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Eye disorders
Ocular surface disease
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Musculoskeletal and connective tissue disorders
Pain: back
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
11.1%
3/27 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Eye disorders
Pain: eye
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Nervous system disorders
Pain: head/headache
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
22.2%
6/27 • Number of events 6 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Pain: rectum
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Musculoskeletal and connective tissue disorders
Pain: joint
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
11.1%
3/27 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Ear and labyrinth disorders
Auditory/Ear - Other (Specify, hearing loss right side)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Blood and lymphatic system disorders
CD4 count
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
55.6%
15/27 • Number of events 37 • Date treatment consent signed to date off study, approximately 45 months.
|
60.0%
3/5 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Cardiac disorders
Cardiac troponin I (cTnl)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, decubitus)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
18.5%
5/27 • Number of events 6 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Blood and lymphatic system disorders
INR (International Normalized Ratio of prothrombin time)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Infections and infestations
Infection - Other (Specify, URI)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: bladder (urinary)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: oral cavity-gums (gingivitis)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: sinus
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: skin (cellulitis)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Lipase
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 6 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic): oral cavity
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
14.8%
4/27 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, genralized or specific area (not due to neuropathy): extraocular
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, genralized or specific area (not due to neuropathy): extremity-lower
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
11.1%
3/27 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, genralized or specific area (not due to neuropathy): whole body/generalized
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
General disorders
Pain: Other (Specify)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
11.1%
3/27 • Number of events 5 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Pain: dental/teeth/periodontal
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Nervous system disorders
Pain: neuralgia/peripheral nerve
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Reproductive system and breast disorders
Pain: pelvis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pain: throat/pharynx/larynx
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
18.5%
5/27 • Number of events 7 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Nervous system disorders
Personality/behavioral
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
11.1%
3/27 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: atrial fibrillation
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
18.5%
5/27 • Number of events 5 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthia (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
General disorders
Weight gain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
General disorders
Weight loss
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
25.9%
7/27 • Number of events 10 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, early satiety)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper respiratory - Other (Specify, mild drain. from podt throat)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Pain: Anus
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Pain: Stomach
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
11.1%
3/27 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
11.1%
3/27 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Cardiac disorders
Cardiac arrhythmia (Other (Specify, tavhycardia)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
11.1%
3/27 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
60.0%
3/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
18.5%
5/27 • Number of events 7 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Infections and infestations
Febrile neutropenia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
18.5%
5/27 • Number of events 8 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory:bronchopulmonary NOS
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
11.1%
3/27 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
22.2%
6/27 • Number of events 6 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Nervous system disorders
Mood alteration:agitation
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Musculoskeletal and connective tissue disorders
Pain: chest wall
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
18.5%
5/27 • Number of events 8 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Musculoskeletal and connective tissue disorders
Pain: chest/thorax NOS
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Musculoskeletal and connective tissue disorders
Pain: muscle
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
11.1%
3/27 • Number of events 5 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
14.8%
4/27 • Number of events 4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Eye disorders
Uveitis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
3.7%
1/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper respiratory - Other (Specify, pulmonary infiltrates)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Ear and labyrinth disorders
Auditory/Ear - Other (Specify, congestion R/ear)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
General disorders
Pain - Other (Specify, left elbow; left flank; left trunk)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 3 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, ARI)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: nose
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
7.4%
2/27 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Renal and urinary disorders
Urine color change
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: Bronchus
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Lung (pneumonia)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils: Rectum
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Infections and infestations
Infection with unknown ANC: Lung (pneumonia)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Infections and infestations
Infection with unknown ANC: Skin (cellulitis)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Infections and infestations
Infection with unknown ANC: upper airway NOS
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
|
Respiratory, thoracic and mediastinal disorders
Obstruction/stenosis of airway: Bronchus
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 45 months.
|
0.00%
0/27 • Date treatment consent signed to date off study, approximately 45 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 45 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place